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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study
Name
Study Status
H070004 Abbott CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) Cardiovascular 10/07/2008 Centrimag PAS Completed
P000039 Abbott Medical THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM Cardiovascular 12/05/2001 Long term Completed
P030035 Abbott Medical ANTHEM AND FRONTIER II CRT-P'S Cardiovascular 05/13/2004 Long term Completed
P030054 Abbott Medical ST JUDE MEDICAL EPIC HF SYSTEM Cardiovascular 06/30/2004 Long Term Completed
P020024 Abbott Medical AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM Cardiovascular 05/14/2003 Long term Completed
P040021 Abbott Medical SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE Cardiovascular 08/05/2005 Biocor & Biocor Supra Valves Completed
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study Completed
5 year long term (IDE) Terminated
P910023  S088 Abbott Medical EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 03/14/2006 EPIC Notifiers Completed
P030054  S019 Abbott Medical EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE Cardiovascular 03/14/2006 Longterm Completed
P060040 Abbott Medical THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 04/21/2008 INTERMACS Registry Completed
H070005 Abbott Medical THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER Cardiovascular 01/10/2017 AMPLATZER PIVSD Occluder PAS Completed
P910023  S154 Abbott Medical PROMOTE CRT-D SYSTEM Cardiovascular 01/13/2009 SJ4 PAS Completed
P030054  S067 Abbott Medical ATLAS II + HF CRT-D SYSTEM Cardiovascular 01/13/2009 SJ4 Post Approval Study Completed
P950022  S042 Abbott Medical RIATA ST OPTIM AND RIATA STS OPTIM Cardiovascular 01/13/2009 SJ4 PAS Completed
P060040  S005 Abbott Medical THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 01/20/2010 Destination Therapy-INTERMACS Completed
Heartmate II Bleeding Study Completed
P030054  S130 Abbott Medical QUICKFLEX U MODEL 1258T LEAD Cardiovascular 05/10/2010 QuickFlex u Model 1258T LV lead Completed
P100009 Abbott Medical MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 New EnrollMitraClip Analysis Cohort (MAC) Completed
P100029 Abbott Medical ST JUDE MEDICAL TRIFECTA VALVE Cardiovascular 04/20/2011 Trifecta Valve PAS Completed
P030054  S173 Abbott Medical CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Cardiovascular 11/29/2011 QUAD PAS Completed
P100045 Abbott Medical CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Cardiovascular 05/28/2014 Newly Enrolled Champion Completed
Champion Substudy Completed
P950022  S085 Abbott Medical OPTISURE Cardiovascular 02/21/2014 OptiSure Lead Post Approval Study Completed
Externalization and Abrasion Sub-Study Completed
P020024  S037 Abbott Medical AMPLATZER DUCT OCCLUDER II Cardiovascular 08/18/2013 Continued F/u of the Premarket ADO II PAS Completed
P140033 Abbott Medical Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software Cardiovascular 01/31/2017 SJM Brady MRI PAS Completed
P810002  S101 Abbott Medical SJM Masters Series Mechanical Heart Valve, 15mm HP Cardiovascular 03/06/2018 Cont f/u of the premarket HALO Cohort Completed
P160054  S008 Abbott Medical HeartMate 3 Left Ventricular Assist System Cardiovascular 10/18/2018 Continued f/u of Premarket Pivotal Cohort Completed
Continued f/u of Continued Access Cohort Completed
P020024  S052 Abbott Medical AMPLATZER Piccolo Occluder Cardiovascular 01/11/2019 Continued FU of IDE/CAP cohort Completed
P100009  S028 Abbott Medical MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System Cardiovascular 03/14/2019 Cont f/u of the COAPT Trival Pivotal Cohort Completed
P110016  S080 Abbott Medical FlexAbility™ Ablation Catheter, Sensor Enabled™ Cardiovascular 12/14/2022 LESS VT Continued F/u of IDE Completed
P040012  S034 ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM Cardiovascular 05/06/2011 CANOPY Trial Completed
P110001 ABBOTT VASCULAR RX HERCULINK ELITE RENAL STENT SYSTEM Cardiovascular 07/20/2011 HERCULES PAS Completed
P110019 ABBOTT VASCULAR Xience Skypoint Everolimus Eluting Coronary Stent System Cardiovascular 11/01/2011 XIENCE PRIME and XIENCE PRIME LL Everolimus Elut Completed
P110019  S066 ABBOTT VASCULAR XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 Extended Followup of the EXPERT CTO Study Completed
P120020 ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) SUPERA PERIPHERAL STENT SYSTEM Cardiovascular 03/28/2014 SUPERB Extended F/U Study Completed
P040038 ABBOTT VASCULAR INC. XACT CAROTID STENT SYSTEM Cardiovascular 09/06/2005 PROTECT Study Completed
EXACT Study Completed
P070015 ABBOTT VASCULAR INC. XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS Cardiovascular 07/02/2008 Longterm IDE Follow up Completed
XIENCE Registry Completed
Dual Antiplatelet Therapy Completed
Fatigue Testing Completed
P070015  S054 ABBOTT VASCULAR INC. XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 05/24/2011 SPIRIT Small Vessel (SV) Registry Completed
P070015  S122 ABBOTT VASCULAR INC. XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 Extended followup of the EXPERT CTO Study Completed
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ABSORB IV Post-Approval Study Completed
ABSORB USA Post Approval Clinical Study Terminated
H040006 ABIOMED, INC. ABIOCOR IMPLANTABLE REPLACEMENT HEART Cardiovascular 09/05/2006 Abiocor Artificial Heart Other
H140001 ABIOMED, INC. IMPELLA RP SYSTEM Cardiovascular 01/23/2015 Impella RP Prospective Study Terminated
Impella RP Pediatric Study Terminated
P140003  S004 ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEMS Cardiovascular 04/07/2016 Impella AMI CS PAS Completed
P140003  S005 ABIOMED, INC. IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM Cardiovascular 04/07/2016 Impella PCCS PAS Completed
P140003  S008 ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEM Cardiovascular 12/01/2016 Impella PROTECTED PCI PAS cVAD Registry Completed
P170011 Abiomed, Inc. Impella RP System Cardiovascular 09/20/2017 Impella RP-RWE Eval and Reporting Completed
Impella RP Pediatric-RWE Eval and Report Completed
P210005 AcuFocus, Inc. IC-8 Apthera Intraocular Lens (IOL) Ophthalmic 07/22/2022 Continuation Study - SAIL-101-PAS Completed
P210014 Advanced Bifurcation Systems Inc. SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System Cardiovascular 12/13/2021 Cont f/u of OPTIMIZE Clinical Study Terminated
DIRECT IV Study Terminated
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Post-Approval Clinical Study Completed
P930014  S045 ALCON LABORATORIES, INC. ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL Ophthalmic 05/03/2011 New Enrollment PAS Completed
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 COMPASS Extension Study Completed
COMPASS XXT Post-Approval Study Completed
CyPass Micro Stent New Enrollment PAS Terminated
P040020  S049 Alcon Research, Ltd. ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS Ophthalmic 12/22/2016 AcrySof IQ ReSTOR +3.0 Toric PAS Completed
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery		 11/17/2006 Core Completed
Focus Group Completed
Adjunct Completed
Informed Decision Process Completed
Re-Op Phase Completed
Device failure Study Other
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery		 02/20/2013 Core Study Completed
Continued Access Study (Natrelle 410 CAS) Completed
Focus Group Study Completed
Case Control Studies Terminated
P110033 Allergan JUVEDERM VOLUMA XC General &
Plastic Surgery		 10/22/2013 VOLUMA-003 Repeat Treatment Study Completed
P900030 Allergan, Inc. CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT Gastroenterology/
Urology		 09/30/1993 Long term Cohort C Completed
P930016  S025 AMO Manufacturing USA, LLC STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM Ophthalmic 07/11/2007 Star 4 Monovision Lasik Other
P050033 Anika Therapeutics, Inc. HYDRELLE General &
Plastic Surgery		 12/20/2006 Elevess CTA Study Completed
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology		 06/14/2016 PATHWAY Clinical Trial PAS Completed
AspireAssist Post-Approval Study Terminated
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 AtriCure Synergy Ablation System Completed
P940016 B. Braun Avitum AG H.E.L.P. SYSTEM Gastroenterology/
Urology		 09/19/1997 Registry Completed
P060002 BARD PERIPHERAL VASCULAR FLAIR ENDOVASCULAR STENT GRAFT Cardiovascular 07/23/2007 FLAIR Endovascular Grafts Completed
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 RESILIENT Completed
CONTINUUM PAS Terminated
P070014  S010 BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 CONTINUUM Long Lesion PAS Terminated
P070014  S022 BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 LifeStent SOLO PAS Terminated
P070014  S037 BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 Popliteal Indication PAS Surv Project Completed
P160024 BARD PERIPHERAL VASCULAR, INC. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT Cardiovascular 04/24/2017 BOLSTER Continued f/u Study Completed
P180037 Bard Peripheral Vascular, Inc. Venovo Venous Stent System Cardiovascular 03/13/2019 VERNACULAR Cont F/u PAS Completed
P180024 BAROnova, Inc TransPyloric Shuttle/TransPyloric Shuttle Delivery Device Gastroenterology/
Urology		 04/16/2019 ENDObesity PAS Other
P010062 BAUSCH & LOMB EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR Ophthalmic 06/07/2004 Long term Completed
P980006  S004 Bausch & Lomb, Inc. PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES Ophthalmic 11/20/2001 Long Term Completed
P030002  S027 Bausch & Lomb, Inc. TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 New Enrollment Study Completed
P830063  S002 BAXTER INTERNATIONAL, INC. GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N Gastroenterology/
Urology		 08/28/2002 Gambro PAS Completed
P020014 BAYER PHARMA AG ESSURE SYSTEM Obstetrics/
Gynecology		 11/04/2002 Newly Trained Physicians Completed
5 year follow up Completed
P020014  S006 BAYER PHARMA AG ESSURE SYSTEM Obstetrics/
Gynecology		 07/22/2004 HSG Evaluation Study Completed
P020014  S012 BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology		 06/15/2007 ESS-305 Completed
P020014  S017 BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology		 02/24/2012 Essure/post-NovaSure PAS Completed
P020014  S041 BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology		 06/29/2015 Post Approval Study Completed
P970018  S033 BD Diagnostic Systems BD SUREPATH COLLECTION VIAL Pathology 12/02/2016 BD SurePath Collection Vial-Post-Approval Study Completed
P160037 BECTON, DICKINSON AND COMPANY BD ONCLARITY HPV ASSAY Microbiology 02/12/2018 BD-USLHPV Post-Approval Study Completed
H100004 Berlin Heart Inc. EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE Cardiovascular 12/16/2011 All Comers Registry Terminated
P160035 Berlin Heart Inc. EXCOR Pediatric Ventricular Assist Device Cardiovascular 06/06/2017 Berlin Heart Comprehensive Reg Based Surv Completed
P000018 BEST VASCULAR, INC BETA-CATH (TM) SYSTEM Cardiovascular 11/03/2000 Beta-Cath Long Term Terminated
P120011 Bimini Health Tech Puregraft Serene Breast Implant General &
Plastic Surgery		 11/14/2014 Post-Approval PMA Cohort Study (PACS) Completed
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 Long Term PAS Completed
P020016 BIOMET MICROFIXATION, INC. WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM Dental 09/21/2005 Long-term Follow-up Study Completed
P050009 Biomet, Inc. C2 A-TAPER ACETABULAR SYSTEM Orthopedic 12/16/2005 Long Term Study Terminated
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 Extended f/u of Premarket Cohort Completed
2-year New Enrollment Study Terminated
P030031 BIOSENSE WEBSTER, INC. BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS Cardiovascular 11/05/2004 Navastar Thermocool Completed
P040036 BIOSENSE WEBSTER, INC. NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER Cardiovascular 08/11/2006 NaviStar Study Completed
P030031  S011 BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 CABANA Trial Completed
Atrial Fibrillation Registry Completed
P030031  S086 BIOSENSE WEBSTER, INC. Visitag Surpoint External Processing Unit (EPU) Cardiovascular 06/01/2018 VISITAG SURPOINT PAS Completed
P170030 Biotronik, Inc ORSIRO Sirolimus Eluting Coronary Stent System Cardiovascular 02/22/2019 Bioflow-V Cont f/u PAS Completed
P050023 BIOTRONIK, INC. TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD Cardiovascular 08/10/2006 COROX LEAD (COSMO) Completed
TUPOS LV Completed
P070008 BIOTRONIK, INC. STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD Cardiovascular 05/12/2008 CELESTIAL Study Completed
P050023  S076 BIOTRONIK, INC. ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry Completed
P980023  S057 BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry Completed
P050023  S087 BIOTRONIK, INC. IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4) Cardiovascular 12/21/2015 ProMRI ICD Post-Approval Study Completed
P950037  S156 BIOTRONIK, INC. SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60 Cardiovascular 06/08/2016 Siello Pacing Lead Study Completed
P050023  S094 BIOTRONIK, INC. IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) Cardiovascular 05/02/2016 ProMRI ICD/CRT-D System Home Monitorin Completed
P160003 BIOTRONIK, INC. PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM Cardiovascular 02/14/2017 Extended Study of Premarket Cohort Completed
P050023  S101 BIOTRONIK, INC. IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-T/INVENTRA 7 VR-T (DF4) Cardiovascular 02/08/2017 ProMRI ICD/CRT-D System Completed
P160025 BIOTRONIK, INC. ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM Cardiovascular 03/23/2017 BIOFLEX-I PAS Completed
P050023  S107 BIOTRONIK, INC. Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization Cardiovascular 05/06/2017 MPP QP-ExCELs Sub-Study PAS Completed
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 Relay Thoracic Stent-Graft w Plus Del Sys Completed
P940008 BOSTON SCIENTIFIC RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS Cardiovascular 11/28/1995 PAS Completed
P050025 BOSTON SCIENTIFIC ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM Cardiovascular 10/27/2006 CABERNET Registry Completed
SONOMA Other
P910073  S077 BOSTON SCIENTIFIC ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES Cardiovascular 11/10/2010 Longitudinal Surveillance Study Completed
P830060  S062 BOSTON SCIENTIFIC LEAD TUNNELER MODEL 6888 Cardiovascular 11/10/2010 Longitudinal Surveillance Study Terminated
P960040  S198 BOSTON SCIENTIFIC TELIGEN 4-SITE MODELS Cardiovascular 11/10/2010 Longitudinal Surveillance Study Completed
P960040  S385 BOSTON SCIENTIFIC NG4 Family of Pulse Generators ICDS. Cardiovascular 05/02/2017 SMART-MSP PAS Completed
MANAGE-HF Completed
P980003 Boston Scientific Corp. CHILLI COOLED RF ABLATION SYSTEM Cardiovascular 02/02/1999 PAS Completed
P920023 Boston Scientific Corp. UROLUME ENDOPROSTHESIS Gastroenterology/
Urology		 05/06/1996 Urolume PAS Completed
P030025 Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 03/04/2004 ARRIVE I Completed
TAXUS (IDE) Completed
P020006 Boston Scientific Corp. ENTERYX PROCEDURE KIT Gastroenterology/
Urology		 04/22/2003 Enteryx Terminated
P000053  S005 Boston Scientific Corp. SPHINCTER 800 URINARY CONTROL SYSTEM Gastroenterology/
Urology		 10/13/2006 Registry AMS MC-0611 Completed
P050019 Boston Scientific Corp. CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS Cardiovascular 10/23/2008 CABANA REGISTRY Completed
BEACH STUDY Completed
P050024 Boston Scientific Corp. CRYOCOR CRYOABLATION SYSTEM Cardiovascular 08/01/2007 Cryocor Ablation PAS Terminated
P030025  S021 Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM Cardiovascular 09/24/2008 5 year clinical outcomes Completed
Fatigue/Matter Testing Completed
P060006 Boston Scientific Corp. BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM Cardiovascular 12/11/2008 BSC Express PAS Completed
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 Outcomes TAXUS ATLAS Completed
TAXUS Registry Completed
Dual Antiplatelet Study Completed
P030025  S028 Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) Cardiovascular 09/24/2008 5 year Clinical Outcomes Completed
Fatigue/Matter Testing Completed
P010012  S160 Boston Scientific Corp. ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 Cardiovascular 05/16/2008 ACUITY Long-Term Registry Completed
P060008  S008 Boston Scientific Corp. TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 05/21/2009 TAXUS ATLAS Small Vessel Completed
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 AIR2 - Extended Study Completed
New Patient Study Completed
P060008  S011 Boston Scientific Corp. TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 07/13/2009 TAXUS Long (S011) Completed
P010012  S212 Boston Scientific Corp. COGNIS 4-SITE MODELS Cardiovascular 11/10/2010 Longitudinal Surveillance Study Completed
P010012  S230 Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 MADIT-CRT ACC NCDR Completed
MADIT-CRT Registry Completed
P100023 Boston Scientific Corp. ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) Cardiovascular 04/22/2011 PERSEUS Workhorse and Small Vessel (SV) Completed
ION Post Approval Study Completed
P110010 Boston Scientific Corp. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 11/22/2011 PROMUS Element Plus US PAS Completed
Continued F/u of Premarket Cohort Completed
P110010  S001 Boston Scientific Corp. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 06/01/2012 PROMUS Element Plus US PAS Completed
Continued F/U of Premarket Cohort Completed
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 Continued f/u of IDE Cohorts Completed
WATCHMAN Comprehensive/Linked-Registry Completed
P010012  S398 Boston Scientific Corp. ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE Cardiovascular 02/22/2016 MOUNTAIN PAS Completed
P010012  S436 Boston Scientific Corp. NG4 Family of Pulse Generators CRT-DS Cardiovascular 05/02/2017 SMART-MSP PAS Completed
MANAGE-HF Completed
P150005  S014 Boston Scientific Corp. Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter Cardiovascular 12/21/2017 INTERRUPT (Zero) AF PAS Completed
P150005  S035 Boston Scientific Corp. Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters Cardiovascular 08/01/2018 INTERRUPT AF PAS Completed
P180011 Boston Scientific Corp. Eluvia Drug-Eluting Vascular Stent System Cardiovascular 09/18/2018 IMPERIAL Continued f/u study Completed
REGAL and EMINENT Long Term f/u studies Completed
P150005  S049 Boston Scientific Corp. IntellaNav MiFi Open-Irrigated Ablation Catheter Cardiovascular 04/17/2020 DirectSense RF Sub-study Completed
P130013  S035 Boston Scientific Corp. WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System Cardiovascular 07/21/2020 PINNACLE FLX Cont f/u of IDE Cohort Completed
P110042 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 S-ICD PAS Registry Completed
P140008 Boston Scientific Corporation ORBERA INTRAGASTRIC BALLOON Gastroenterology/
Urology		 08/05/2015 ORBERA PAS (OPAS-001) Completed
P140012 Boston Scientific Corporation RESHAPE INTEGRATED DUAL BALLOON SYSTEM Gastroenterology/
Urology		 07/28/2015 REDUCE PAS Terminated
P140026 Boston Scientific Corporation ENROUTE TRANSCAROTID STENT SYSTEM Cardiovascular 05/18/2015 ROADSTER 2 Registry Completed
P140028 BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM Cardiovascular 07/21/2015 SuperNOVA Continued f/u study Completed
P150003 BOSTON SCIENTIFIC CORPORATION SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 10/02/2015 EVOLVE Short DAPT Study Completed
P110042  S058 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 08/08/2016 EMBLEM MRI S-ICD Pt Mgmt System Surv PAS Completed
P150003  S039 BOSTON SCIENTIFIC CORPORATION SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Cardiovascular 10/18/2018 EVOLVE 4.5/5.0 Study Completed
P180013 Boston Scientific Corporation VICI VENOUS STENT System Cardiovascular 05/02/2019 VIRTUS Continued Follow-up Study Completed
P180029 Boston Scientific Corporation LOTUS Edge Valve System Cardiovascular 04/23/2019 Cont F/u of REPRISE III Trial Premarket Cohorts Completed
RWU of LOTUS Edge Valve System Completed
P190019 Boston Scientific Corporation Ranger™ Paclitaxel-Coated PTA Balloon Catheter Cardiovascular 10/30/2020 RANGER II SFA Cont F/u Study Completed
Range Long Balloon, Ranger China & COMPARE I f/u Completed
P150003  S054 BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System Cardiovascular 01/22/2021 Synergy Megatron PAS Completed
P150003  S055 BOSTON SCIENTIFIC CORPORATION SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™) Cardiovascular 05/28/2020 SYNERGY PAS Completed
P200029 Boston Scientific Corporation TheraSphere Radiology 03/17/2021 The Patient Exposure Study Completed
P140004 Boston Scientific Neuromodulation SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 SPACER Completed
P040016 BOSTON SCIENTIFIC SCIMED, INC. VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM Cardiovascular 04/12/2005 Longterm Outcomes Completed
P150012 BOSTONSCIENTIFIC IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD Cardiovascular 04/25/2016 INGEVITY and SAMURAI Completed
P150012  S083 BOSTONSCIENTIFIC Ingevity + Lead - Active Fixation Cardiovascular 12/16/2019 INGEVITY+ Post Approval Study Completed
P170042 C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 07/30/2018 AVeVA Continued F/U Post-Approval Study Completed
P170042  S002 C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 03/01/2019 AVeNEW Cont f/u Study Completed
P030030 C.R. Bard, Inc. URYX URETHRAL BULKING AGENT Gastroenterology/
Urology		 12/16/2004 Tegress PAS Terminated
P150017 Cartiva, Inc CARTIVA SYNTHETIC CARTILAGE IMPLANT Orthopedic 07/01/2016 MOTION Extend Study Completed
P160014 CELONOVA BIOSCIENCES, INC. COBRA PzF NanoCoated Coronary Stent System Cardiovascular 02/21/2017 Cont f/u of PzF SHIELD IDE Cohort Completed
P050010 Centinel Spine, LLC PRODISC -L TOTAL DISC REPLACEMENT DEVICE Orthopedic 08/14/2006 PRODISC-L Long Term Study Completed
P070001 Centinel Spine, LLC PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 Long Term Study Completed
Enhanced Surveillance Study Completed
P010001 CERAMTEC GMBH CERAMIC TRANSCEND HIP ARTICULATION SYSTEM Orthopedic 02/03/2003 Ceramic Transcend Hip Completed
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 Post-Approval Study Completed
P180032 Channel Medsystems, Inc. Cerene® Cryotherapy Device Obstetrics/
Gynecology		 03/28/2019 CLARITY Clinical Post-Approval Study Completed
P970051  S028 Cochlear Americas NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/01/2005 Pediatric Study Completed
Adult Study Completed
P130016 Cochlear Americas NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 Extended f/u study Completed
New Enrollment Study Completed
P970051  S172 Cochlear Americas NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/17/2020 Nucleus 24 Pediatric Post-Approval Study Completed
P070013 COLBAR LIFESCIENCE LTD. EVOLENCE COLLAGEN FILLER General &
Plastic Surgery		 06/27/2008 EVOLENCE Terminated
P000006 COLOPLAST CORP. TITAN INFLATABLE PENILE PROSTHESIS Gastroenterology/
Urology		 07/14/2000 Coloplast PAS Completed
P060023 Companion Spine France S.A.S BRYAN CERVICAL DISC PROSTHESIS Orthopedic 05/12/2009 Long-Term Study Completed
Enhanced Surveillance Completed
P100022 Cook Ireland, Ltd. ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 New US Enrollment Completed
Zilver PTX Stent PAS Completed
P100028 COOK MEDICAL INCORPORATED FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM Cardiovascular 01/14/2011 REFORM Completed
P140016 COOK MEDICAL INCORPORATED ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT Cardiovascular 09/15/2015 Post-Approval Study Completed
P020018  S005 COOK, INC. ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM Cardiovascular 06/09/2005 Postmarket Surveillance Registry Completed
P020018  S010 COOK, INC. 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT Cardiovascular 09/07/2006 AAA Flex 36mm Completed
P020018  S040 COOK, INC. ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 Long Term F/U Study Completed
Training Program Completed
P000032  S028 CooperSurgical, Inc. HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM Obstetrics/
Gynecology		 03/27/2009 Her Option PAS Completed
P160047 CooperSurgical, Inc. AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT Obstetrics/
Gynecology		 06/14/2017 AEGEA Pivotal Clinical Study Completed
P050031 CooperVision, Inc. PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY Ophthalmic 11/16/2006 Paragon PAS Completed
P060038  S017 CORCYM Canada Corp. MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL Cardiovascular 04/18/2014 NEMO PAS Terminated
P990036 CORDIS CORP. CORDIS CHECKMATE(TM) SYSTEM Cardiovascular 11/03/2000 PAS Completed
P020026 CORDIS CORP. CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER Cardiovascular 04/24/2003 Bench Testing Completed
P020026  S017 CORDIS CORP. RAPTORRAIL RX SDS, 2.25MM CYPHER STENT Cardiovascular 09/18/2009 CYPHER MINI Completed
P030047 Cordis US Corporation CORDIS PRECISE NITINOL STENT SYSTEM Cardiovascular 09/22/2006 Longterm & CASES Studies Completed
P120002 Cordis US Corporation SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS Cardiovascular 11/07/2012 STROLL Post Approval Study Completed
P150002 Cordis US Corporation INCRAFT(R) AAA STENT GRAFT SYSTEM Cardiovascular 11/27/2018 Long Term INSPIRATION Study Completed
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 Long Term Study Completed
New Enrollment Completed
P120023 CorneaGen KAMRA INLAY Ophthalmic 04/17/2015 Continuation Study Completed
New Enrollment Study Terminated
H110002 Cortigent, Inc. ARGUS II RETINAL PROSTHESIS SYSTEM Ophthalmic 02/13/2013 Ext f/u of the Argus II Feasibility Study Completed
New Enrollment Argus II Terminated
P970029 CRYOLIFE, INC. TMR HOLMIUM LASER SYSTEM Cardiovascular 02/11/1999 TMR Completed
P970029  S014 CRYOLIFE, INC. CARDIOGENESIS HOLMIUM TMR SYSTEM Cardiovascular 02/22/2012 PEARL 8.0 New Enrollment Study Other
P180050 CVRx, INC. BAROSTIM NEO® System Cardiovascular 08/16/2019 Extended Phase BeAT-HF PAS Completed
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Prospective Post-Approval Study Terminated
DePuy Outcome Tracking Sys Registry(DOTS) Terminated
Kaiser Permanente Joint Registry Terminated
Natl Joint Registry for England and Wales Terminated
Australian Ortho Assc Natl Joint Registry Terminated
New England Bapt Hospital Joint Registry Terminated
P070026 DEPUY ORTHOPAEDICS, INC. CERAMAX CERAMIC HIP SYSTEM Orthopedic 12/23/2010 Ceramax PAS Completed
P090002 DEPUY ORTHOPAEDICS, INC. PINNACLE COMPLETE ACETABULAR HIP SYSTEM Orthopedic 06/13/2011 Pinnacle CoMplete Acetabular Hip System Terminated
P070026  S004 DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 Long-Term F/U of IDE COC36 patients Completed
Short-Mid-Term F/u of New COC36 patients Completed
COC36 PAS: UK & Australian Natl Joint Reg Completed
P040006 DEPUY SPINE,INC CHARITE ARTIFICIAL DISC Orthopedic 10/26/2004 Charite Artificial Disc Terminated
P110014 Dilon Medical Technologies, Ltd. DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery		 12/27/2012 MarginProbe System US PAS Completed
P050050 DJO Global SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 Long Term Study Completed
N980003 DJO SURGICAL KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM Orthopedic 11/26/2003 Encore Keramos PDP Study Completed
P110021 EDWARDS LIFESCIENCES LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/19/2012 Continue F/u of Premarket Cohort Completed
Newly Enrolled Study Completed
P870077 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS Cardiovascular 09/25/1991 PAS Completed
P010041 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) Cardiovascular 06/24/2002 Long term Completed
P860057  S016 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Cardiovascular 11/29/2001 PAS Completed
P010041  S002 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert Completed
P870077  S013 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert Completed
P000007  S003 EDWARDS LIFESCIENCES, LLC. EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert Completed
P860057  S019 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Cardiovascular 05/09/2003 PERIMOUNT Plus Pericardial Bioprosthesis Model 6900P Completed
P870056  S015 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND Cardiovascular 08/22/2003 Tag Alert Completed
P860057  S018 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC Cardiovascular 11/14/2003 Perimount Magna Pericardial Bioprosthesis Completed
P860057  S023 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX Cardiovascular 04/07/2005 Carpentier Edwards PAS Completed
P860057  S029 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term Completed
P860057  S042 EDWARDS LIFESCIENCES, LLC. CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 05/07/2009 Clinical Study Completed
P100041 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 11/02/2011 Continue Follow-Up of Premarket Cohort Completed
Newly Enrolled Study Completed
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 Cont F/U of the IDE inop pts cohort(B) Completed
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 Continued f/u of premarket cohort Completed
P130009  S034 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 Continued f/u of the premarket cohort Completed
P130009  S037 EDWARDS LIFESCIENCES, LLC. SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 02/29/2016 COMPASSION Cohort Completed
P130009  S057 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort Completed
H080005 ELANA INC. ELANA ARTERIOTOMY SYSTEM Neurology 03/10/2011 Elana Surgical KitHUD Other
P040002 Endologix, LLC ENDOLOGIX POWERLINK SYSTEM Cardiovascular 10/29/2004 Long Term/Pivotal Cohort Completed
P120006 Endologix, LLC OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 Long Term Follow-up Study Completed
Training Program Completed
P120006  S031 Endologix, LLC Alto Abdominal Stent Graft System Cardiovascular 03/13/2020 Case Selection and Sizing Study Completed
P220021 Endologix, LLC DETOUR System Cardiovascular 06/07/2023 DETOUR2 Continued Follow-up Study Completed
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 Extended Follow-up of PMA study Completed
Esteem New Enrollment 2 Completed
P040029 Euclid Vision Corporation Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear Ophthalmic 09/29/2004 JSZ Orthokeratology Contact Lenses Completed
P030004 EV3 NEUROVASCULAR ONYX LIQUID EMBOLIC SYSTEM Neurology 07/21/2005 Long Term Study Completed
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 Cologuard PAS Completed
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Novation PAS Terminated
P170019  S016 Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 06/16/2020 Post-Approval Study Terminated
P170019  S017 Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 10/23/2020 NTRK Clinical Efficacy PAS for Larotrectinib Completed
P200006 Foundation Medicine, Inc. FoundationOne Liquid CDx (F1 Liquid CDx) Pathology 10/26/2020 ARIEL2 PAS Terminated
P170019  S029 Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 02/18/2022 MK-3475 MSI-H FMI F1CDx Post Approval Analysis Completed
P100042 GEN-PROBE INCORPORATED APTIMA HPV ASSAY Microbiology 10/28/2011 APTIMA HPV Assay Completed
P120007 GEN-PROBE INCORPORATED APTIMA HPV 16 18/45 GENOTYPE ASSAY Microbiology 10/12/2012 HPVGTS-US-10-002 Completed
P030032 GENZYME BIOSURGERY HYLAFORM (HYLAN B GEL) General &
Plastic Surgery		 04/22/2004 Fitzpatrick skin types Completed
P170043 Glaukos Corporation iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) Ophthalmic 06/21/2018 Extended f/u Premarket Cohort Completed
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 Extended F/u of IDE Cohort Study Completed
New Enrollment Study Completed
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Extended f/u of premarket cohort Completed
Enhanced Surveillance Completed
P970021  S014 GYNECARE, INC. GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM Obstetrics/
Gynecology		 07/06/2007 Long-Term Study Completed
H060002 Gyrus ACMI, Inc. IBV VALVE SYSTEM Anesthesiology 10/24/2008 IBV Valve Completed
P180007 Gyrus ACMI, Inc. Spiration® Valve System Anesthesiology 12/03/2018 EMPROVE Extension Study Completed
P040052 HOLOGIC, INC. MONOPREP PAP TEST Pathology 03/03/2006 SURE Study Completed
CHOICE Study Other
P070022 HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM Obstetrics/
Gynecology		 07/06/2009 EASE TRIAL Terminated
P080014 HOLOGIC, INC. CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT Microbiology 03/12/2009 Cervista HPV HR Assay Completed
P080015 HOLOGIC, INC. CERVISTA HPV 16/18 Microbiology 03/12/2009 Cervista HPV HR Assay Completed
P010013  S041 HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology		 02/01/2013 NovaSure PAS Completed
P950039  S026 HOLOGIC, INC. THINPREP-5000 Pathology 03/02/2015 ThinPrep 5000-Post-Approval Study Completed
P000013 HOWMEDICA OSTEONICS CORP. TRIDENT SYSTEM Orthopedic 02/03/2003 Osteonics Long Term Completed
P080012 Infusyn Therapeutics, LLC PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 Prometra Programmable Pump System Completed
P110039 InSightec EXABLATE General &
Plastic Surgery		 10/18/2012 New Enrollment Study Completed
Enhanced Surveillance Registry Study Completed
P150038 InSightec EXABLATE Neurology 07/11/2016 Long Term PAS Completed
P040003 INSIGHTEC, LTD EXABLATE 2000 SYSTEM Obstetrics/
Gynecology		 10/22/2004 Long Term Exablate Study Completed
P040003  S006 INSIGHTEC, LTD EXABLATE 2100 SYSTEM Obstetrics/
Gynecology		 12/22/2009 Exablate 2100 Type 1.0 Completed
P040003  S016 INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology		 10/05/2015 Study to Evaluate Safety of ExAblate Completed
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 Ext FU Premkt Cohort Inspire 4 STAR Trial Completed
P040034 INTEGRA LIFESCIENCES CORPORATION DURASEAL DURAL SEALANT SYSTEM Neurology 04/07/2005 Duraseal Completed
P080013 INTEGRA LIFESCIENCES CORPORATION DURASEAL EXACT SPINE SEALANT SYSTEM Neurology 09/04/2009 DuraSeal Exact Spine Sealant System Completed
P890055  S026 Intera Oncology CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 Leachables Study Completed
Drug Stability Study Completed
Long-Term Surveillance of MedStream Other
P170034 Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC HYDRUS MICROSTENT Ophthalmic 08/10/2018 Continuation of Premarket Cohort PAS Completed
P060017 JANSSEN DIAGNOSTICS GENESEARCH BREAST LYMPH NODE(BLN) ASSAY Pathology 07/16/2007 PPC Study Other
TS Study Other
P980040  S039 Johnson & Johnson Surgical Vision, Inc. TECNIS TORIC 1-PEICE INTRAOCULAR LENS Ophthalmic 04/15/2013 New Enrollment of Post Approval Study Completed
P980040  S058 Johnson & Johnson Surgical Vision, Inc. TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU Ophthalmic 07/31/2015 ECR IOL PAS Completed
P980040  S065 Johnson & Johnson Surgical Vision, Inc. TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS Ophthalmic 07/15/2016 TECNIS Symfony Toric New Enrollment Study Completed
P950015 Laser Engineering Heart Inc. THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION Cardiovascular 08/20/1998 Heart Laser CO2 Completed
P160045  S027 LIFE TECHNOLOGIES CORPORATION Oncomine™ Dx Target Test Pathology 12/01/2021 PAS Clinical Study Completed
P970003  S050 LivaNova USA, Inc. VNS THERAPY SYSTEM Neurology 07/15/2005 Registry Study Completed
Dosing Study D-21 Completed
P110032 Lombard Medical Limited AORFIX FLEXIBLE STENT GRAFT SYSTEM Cardiovascular 02/14/2013 Comprehensive/Linked-Registry Based Surv Other
Aorfix Post Approval Study Terminated
P130024 LUTONIX LUTONIX DRUG COATED BALLOON PTA CATETER Cardiovascular 10/09/2014 PAS 1 (Extended Follow-up Study) Completed
(New Enroll of Female Pt Study)SAFE-DCB RW US Std Completed
P130024  S009 LUTONIX LUTONIX 035 DRUG COATED BALLOON PTA CATHETER Cardiovascular 02/07/2017 ISR and LL Cohorts of the Global SFA Reg Completed
SFA ISR IDE Continued f/u study Completed
Lutonix Long Lesion SFA Cont f/u study Completed
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 IDE Cohort Post Approval Study Completed
P040013  S009 Lynch Biologics LLC GEM 21S (GROWTH ENHANCED MATRIX) Dental 08/10/2007 Working Standard for Biomatrix Completed
P040013  S016 Lynch Biologics LLC GEM 21S GROWTH FACTOR ENHANCED MATRIX Dental 05/27/2011 GEM21S Growth Factor Completed
P000025  S084 MED-EL CORP. MED-EL COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 09/15/2016 MED-EL EAS Extended f/u Study Completed
P030006 MEDIFOCUS, INC PROLIEVE THERMODILATATION SYSTEM Gastroenterology/
Urology		 02/19/2004 Prolieve PAS Completed
P110004 MEDINOL LTD. PRESILLION PLUS COCR CORONARY STENT RX SYSTEM Cardiovascular 04/12/2012 Continued f/u of BLAST Placebo Cohort Completed
Enrollment of New US Cohort Other
P110004  S001 MEDINOL LTD. NIRXCELL COCR CORONARY STENT ON RX SYSTEM Cardiovascular 12/19/2013 NIRTRAKS PAS Completed
P170008 Medinol, Ltd. EluNIR™ Ridaforolimus Eluting Coronary Stent System Cardiovascular 11/28/2017 Cont f/u of BIONICS Clinical Study Completed
H160002 Medos International, SARL PulseRider Aneurysm Neck Reconstruction Device Neurology 06/19/2017 ANSWER Clinical Study Completed
P100047 Medtronic HEARTWARE VENTRICULAR ASSIST SYSTEM Cardiovascular 11/20/2012 Newly Enrolled (HW-PAS-01) Completed
Training Program (HeartWare-PAS-02) Completed
Continued Follow-Up (HW-PAS-03) Completed
P100047  S090 Medtronic HeartWare™ HVAD™ System Cardiovascular 09/27/2017 Cont F/u of HW004-A ENDURANCE Completed
P990046 MEDTRONIC ATS MEDICAL, INC. ATS OPEN PIVOT BILEAFLET HEART VALVE Cardiovascular 10/13/2000 Wear testing Completed
P010031  S104 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/INSYNC SENTRY/INSYNC MAXIMO Cardiovascular 08/28/2008 Enhanced Surveillance Completed
P980016  S135 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR Cardiovascular 08/28/2008 Enhanced Surveillance Completed
P010031  S176 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 Chronic Lead Performance Completed
P980016  S216 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 Chronic Lead Performance Completed
P010031  S232 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT Cardiovascular 04/04/2012 REVERSE NCDR ICD Registry Study Completed
REVERSE Product Surveillance Registry Completed
P010031  S344 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D Cardiovascular 09/25/2013 LIA in Non-MDT Leads Surveillance Update Analysis Completed
P980016  S394 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD Cardiovascular 09/25/2013 LIA in Non-MDT Leads Surveillance Update Analysis Completed
P980016  S536 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S Cardiovascular 09/11/2015 MR conditional Tachy Therapy Systems Completed
P010031  S513 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Study Completed
P980016  S555 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE Cardiovascular 04/28/2016 PCT Change Study Completed
P980016  S586 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT EVERA MRI XT DR SURESCAN MODEL DDMB1D1, EVERA MRI XT VR SURESCAN MODEL DVMB1D1, EVERA MRI S DR SURESCAN MODEL DDMC3D1, EVERA MRI S VR SURESCAN MODEL DVFC3D1, VISIA AF MRI XT SURESCAN MODEL DVFB1D1, VISIA AF MRI S SURESCAN MODEL DVFC3D1 IMPLANTABLE, CARDIOVERTER DEFIBRILLATORS (ICDs) AND PROGRAMMER SOFTWARE MODEL SW033 Cardiovascular 10/12/2016 MR conditional Tachy Therapy Systems Stud Completed
P830061  S129 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574. Cardiovascular 10/12/2016 MR conditional Tachy Therapy Systems Completed
P010031  S563 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchronization. Cardiovascular 03/24/2017 MPP PAS Completed
P020045 Medtronic CryoCath LP 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM Cardiovascular 04/17/2003 CryoFACTS Completed
P100010 Medtronic CryoCath LP ARCTIC FRONT CRYOCATHETER SYSTEM Cardiovascular 12/17/2010 STOP AF PAS Completed
P950024 MEDTRONIC Inc. MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 Cardiovascular 09/06/1996 Unipolar Model 4965 Completed
P960009 MEDTRONIC Inc. MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM Neurology 07/31/1997 Neurotoxicity/Carcinogenicity Completed
Mortality and Autopsy Completed
P980050 MEDTRONIC Inc. MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF Cardiovascular 06/14/2000 RESPECT Completed
P010015 MEDTRONIC Inc. MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM Cardiovascular 08/28/2001 Registry Completed
P950024  S002 MEDTRONIC Inc. MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 Cardiovascular 09/16/1999 Bipolar Model 4968 Completed
P960009  S007 MEDTRONIC Inc. MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM Neurology 01/14/2002 VA Study Completed
P980035  S013 MEDTRONIC Inc. MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE Cardiovascular 03/26/2003 RESPECT Completed
P860004  S056 MEDTRONIC Inc. SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM General Hospital 09/12/2003 Synchromed II Completed
P060025 MEDTRONIC Inc. ATS 3F AORTIC BIOPROSTHESIS Cardiovascular 10/30/2008 ATS 3f Other
P060033 MEDTRONIC Inc. ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 02/01/2008 5yr Clinical Outcomes Completed
Registry PROTECT CA Completed
Dual Antiplatelet Therapy EDUCATE Completed
Product Testing Completed
P060039 MEDTRONIC Inc. ATTAIN STARFIX MODEL 4195 LEAD Cardiovascular 06/13/2008 Chronic Extraction Completed
Chronic Performance Study Completed
P980035  S073 MEDTRONIC Inc. MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE Cardiovascular 05/13/2008 Longterm Study PAS Completed
P080006 MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD Cardiovascular 04/07/2009 Elution Completed
Chronic Lead Performance Completed
P080006  S002 MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD Cardiovascular 04/01/2011 Chronic Lead Performance Completed
P080006  S004 MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD Cardiovascular 03/31/2011 Attain Ability Straight Model 4396 Completed
P920015  S055 MEDTRONIC Inc. MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M Cardiovascular 01/09/2012 Chronic Lead Performance Completed
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 PAS of TS Feat w/sensor-aug w/comm data Completed
P980035  S277 MEDTRONIC Inc. ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR Cardiovascular 01/15/2013 SureScan Pacing System Completed
P080006  S068 MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD Cardiovascular 08/01/2014 Post-Approval Study Registry Completed
P140010 MEDTRONIC Inc. IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Cardiovascular 12/30/2014 IN.PACT SFA Extended f/u study Completed
Cont f/u of Sub in SFA Global Clin Prog Completed
P140017 MEDTRONIC Inc. MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) Cardiovascular 01/27/2015 Long Term PAS Completed
New Enrollment Study Completed
P080006  S073 MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS Cardiovascular 12/10/2014 Post-Approval Study Registry Completed
P920015  S151 MEDTRONIC Inc. SPRINT QUATTRO SECURE S MRI SURESCAN AND SPRINT QUATTRO SECURE MRI SURESCAN Cardiovascular 09/11/2015 MR conditional Tachy Therapy Systems Completed
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 Micra Rate Resp Conf Study Completed
P080006  S085 MEDTRONIC Inc. ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Completed
P920015  S163 MEDTRONIC Inc. SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Completed
P980035  S442 MEDTRONIC Inc. ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE Cardiovascular 04/28/2016 PCT Change Study Completed
P920015  S166 MEDTRONIC Inc. SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M,SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M Cardiovascular 04/28/2016 PCT Change Study Completed
P140010  S015 MEDTRONIC Inc. IN PACT(TM) ADMIRAL(TM) PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 09/07/2016 Surveillance Post Market Registry Completed
P920015  S178 MEDTRONIC Inc. SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1) Cardiovascular 10/12/2016 MR conditional Tachy Therapy Systems Completed
P980022  S012 MEDTRONIC MINIMED GUARDIAN RT Clinical Chemistry 08/24/2005 PXX/GS041/A Completed
P970004  S022 MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology		 09/24/2002 Single Tined Lead (protocol 1634) Completed
P080025 MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM Gastroenterology/
Urology		 03/14/2011 FI-PAS Completed
P090029 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 07/24/2014 Extended Follow-Up Completed
P090029  S003 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP(TM) CERVICAL DISC Orthopedic 07/07/2016 10 Year Extended f/u of IDE Subjects Completed
PRESTIGE LP 2-Level Metal Concentrations Completed
P040001 MEDTRONIC SOFAMOR DANEK, INC. X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM Orthopedic 11/21/2005 LTOS Study Completed
COAST Study Terminated
P060018 MEDTRONIC SOFAMOR DANEK, INC. PRESTIGE CERVICAL DISC SYSTEM Orthopedic 07/16/2007 Long-Term Study Completed
Enhanced Surveillance Completed
P990020 Medtronic Vascular ANEURX STENT GRAFT SYSTEM Cardiovascular 09/28/1999 Long term Completed
P070007 Medtronic Vascular TALENT THORACIC STENT GRAFT SYSTEM Cardiovascular 06/05/2008 THRIVE Trial Terminated
P070012 Medtronic Vascular EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM Cardiovascular 10/23/2007 MAVErIC II Long Term Study Completed
EMERGE Terminated
P070027 Medtronic Vascular THE TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 04/15/2008 Vitality Trial Completed
P070027  S011 Medtronic Vascular TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 02/04/2010 Registry Terminated
P100021 Medtronic Vascular MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM Cardiovascular 12/16/2010 ENGAGE Completed
P100040 Medtronic Vascular VALIANT THORACIC STENT GRAFT SYSTEM Cardiovascular 04/01/2011 Captivia Delivery System Completed
P110013 Medtronic Vascular RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/17/2012 Resolute Integrity Completed
Cont Followup of Premarket and OUS Cohort Completed
P110040 Medtronic Vascular MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM Cardiovascular 09/19/2013 Complete SE SFA Long Term Study Completed
P110013  S005 Medtronic Vascular RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/22/2013 Resolute Integrity PAS Newly Enrolled Completed
Continued F/u of Premarket and OUS Cohort Completed
P100040  S012 Medtronic Vascular VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 Comprehensive/Linked-Registry Based Surv. Completed
Valiant Dissection PAS Terminated
P160043 MEDTRONIC VASCULAR RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 04/28/2017 Cont f/u RESOLUTE ONYX Clinical Completed
RESOLUTE ONYX PAS Completed
P160043  S001 MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 11/16/2017 Cont f/u of RESOLUTE ONYX 2.0 Clinical Completed
RESOLUTE ONYX PAS Completed
P160043  S012 MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 12/14/2018 RESOLUTE ONYX CTO Post-approval study Completed
P110013  S088 Medtronic Vascular Resolute Integrity Zotarolimus-Eluting Coronary Stent System Cardiovascular 12/14/2018 RESOLUTE ONYX CTO Post-approval study Completed
P100040  S036 Medtronic Vascular Valiant Navion Thoracic Stent Graft System Cardiovascular 10/19/2018 Continued f/u Valiant EVO Study Completed
P060001 MEDTRONIC VASCULAR INC PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS Cardiovascular 01/24/2007 CREATE PAS Completed
CREATE (IDE) Completed
P110023 MEDTRONIC VASCULAR INC EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Cardiovascular 03/07/2012 Durability PAS Completed
Cont FU of Premarket Cohort-Durability II PAS Completed
P190008 Medtronic Vascular Inc. IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Cardiovascular 11/21/2019 IN.PACT AV Access IDE Cohort PAS Completed
P200026 Medtronic Vascular, Inc. Abre Venous Self-expanding Stent System Cardiovascular 10/21/2020 ABRE Continued Follow-up Study Completed
H080002 Medtronic, Inc MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM Cardiovascular 01/25/2010 Long Term PAS Terminated
Generalizability Study Terminated
P090013 Medtronic, Inc REVO MRI SURESCAN IPG AND PACING SYSTEM Cardiovascular 02/08/2011 Chronic Lead Performance/Multiple MRI Completed
P090013  S202 Medtronic, Inc CAPSUREFIX MRI SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Completed
P090013  S205 Medtronic, Inc CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI Cardiovascular 04/28/2016 PCT Change Study Completed
P090013  S225 Medtronic, Inc CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI Cardiovascular 10/12/2016 MR conditional Tachy Therapy Systems Stud Completed
P890003  S119 Medtronic, Inc. CARELINK MONITOR MODEL 2490H Cardiovascular 05/13/2008 Longterm PAS Completed
P890003  S179 Medtronic, Inc. CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE Cardiovascular 01/09/2012 Chronic Lead Performance Completed
P130021 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 New Enrollment of extreme risk patients Terminated
P130021  S002 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 Continued f/u of the premarket cohorts Completed
P130021  S010 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 03/30/2015 Continued f/u of the premarket cohort Completed
P140032 Medtronic, Inc. Implantable System for Remodulin General Hospital 12/22/2017 Post-Approval Study Terminated
P130021  S014 Medtronic, Inc. COREVALVE (TM) EVOLUT(TM) R SYSTEM Cardiovascular 06/22/2015 Continued f/u of premarket cohort Completed
P130021  S016 Medtronic, Inc. MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS Cardiovascular 11/10/2015 Continued f/u of premarket cohort Completed
P930039  S140 Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Completed
P930039  S142 Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 Cardiovascular 04/28/2016 PCT Change Study Completed
P930039  S151 Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 Cardiovascular 10/12/2016 MR conditional Tachy Therapys Systems Completed
P130021  S025 Medtronic, Inc. Medtronic CoreValve Evolut R XL system Cardiovascular 10/26/2016 Continued f/u of premarket cohort Completed
P130021  S029 Medtronic, Inc. Medtronic CoreValve Evolut PRO System Cardiovascular 03/20/2017 Cont f/u of CoreValve Evolut PRO System Completed
P990018  S002 MENICON CO. LTD. MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR Ophthalmic 07/12/2002 Menicon RGP Terminated
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery		 11/17/2006 Informed Decision Process Completed
Adjunct Study Completed
Core Completed
Focus Group Completed
Re-Op Phase Completed
Device Failure Study Other
Breast Implant Case Control Studies Terminated
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery		 06/14/2013 Post-Approval PMA Cohort Study (PACS) Completed
Post-approval Cont Access Study (PACAS) Completed
Focus Group Study Completed
Breast Implant Case-Control Studies Terminated
P040047 MERZ NORTH AMERICA, INC COAPTITE Gastroenterology/
Urology		 11/10/2005 Coaptite Completed
P050037 MERZ NORTH AMERICA, INC RADIESSE 1.3CC AND 0.3CC General &
Plastic Surgery		 12/22/2006 Radiesse Completed
P050052 MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery		 12/22/2006 Long Term (Nasolabial Folds) Completed
Short Term (Fitzpatrick) Completed
P090016 MERZ NORTH AMERICA, INC BELOTERO BALANCE General &
Plastic Surgery		 11/14/2011 Chemical/Physical Evaluation Completed
Concentration and Molecular Weight Completed
Belotero Balance PAS Completed
P050052  S049 MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery		 06/04/2015 Radiesse Radiological Evaluation Study Completed
Radiesse New Enrollment Study Completed
P100018 Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE Neurology 04/06/2011 Continued Follow-up of Premarket Cohort Completed
P100018  S015 Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR Pipeline Flex Embolization Device Neurology 12/14/2018 PREMIER Post-Approval Study Completed
P230002 MicroCube, LLC Minitouch 3.8 Era System (Minitouch System) Obstetrics/
Gynecology		 07/28/2023 EASE Clinical Trial Completed
P980049  S020 MicroPort CRM USA Inc. OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD Cardiovascular 04/28/2006 Ovatio DR6550 Study Completed
P060027 MicroPort CRM USA Inc. OVATIO CRT SYSTEM Cardiovascular 05/15/2008 Long Term Other
P030027 MicroPort Orthopedics Inc. CERAMIC TRANSCEND HIP ARTICULATION Orthopedic 07/07/2003 Ceramic Transcend Hip Completed
P030042 MicroPort Orthopedics Inc. CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM Orthopedic 11/03/2009 ConservePlus Longer-Term PAS Terminated
ConservePlus New Enrollment PAS Terminated
P020031 MICROSULIS MEDICAL LTD. MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM Obstetrics/
Gynecology		 09/23/2003 MEA PAS Completed
P170032 MicroVention, Inc. Woven EndoBridge (WEB) Aneurysm Embolization System Neurology 12/31/2018 PAS2 - WEB-IT Study Completed
P170013  S005 MicroVention, Inc. Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Neurology 09/16/2021 LVIS X PAS Other
P140013 MINERVA SURGICAL MINERVA ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology		 07/27/2015 Minerva Single-Arm Study Completed
Minerva Pivotal Study Completed
P000040  S014 Minerva Surgical, Inc. GENESYS HTA SYSTEM Obstetrics/
Gynecology		 04/23/2010 Genesys HTA Post Approval Registry Completed
P040025 Natus Medical Incorporated OLYMPIC COOL-CAP Neurology 12/20/2006 VON Registry Completed
P010047 NEOMEND, INC. PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 01/14/2010 Long Term Safety Completed
P010047  S010 NEOMEND, INC. NEOMEND PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 12/21/2011 NeoMend ProGel Pleural Air Leak Sealant Completed
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 Continued F/u -Long Term Treatment (LTT) Completed
Lead Extraction Study Completed
Autopsy Study Completed
H100002 NEUROVASX CPAX ANEURYSM TREATMENT SYSTEM Neurology 04/01/2011 New Enrollment Study Other
P000023 NEXUS CMF, LLC TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES Dental 01/05/2001 TMJ Fossa-Eminence PAS Completed
P000035 NEXUS CMF, LLC TMJ FOSSA-EMINENCE PROSTHESIS(TM) Dental 02/27/2001 TMJ Completed
P000049 NMT MEDICAL, INC. CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD Cardiovascular 12/05/2001 Prospective VSD Registry Other
P000049  S016 NMT MEDICAL, INC. STARFLEX SEPTAL OCCLUSION SYSTEM Cardiovascular 03/05/2009 Fatigue & Corrosion Testing Other
P100034 Novocure GmbH NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 Registry Study for Optune System Completed
P100012 NUVASIVE, INC. NUVASIVE PCM CERVICAL DISC SYSTEM Orthopedic 10/26/2012 PCM Cervical Long Term Completed
PCM Cervical Enhanced Surveillance Terminated
P200022 NuVasive, Inc. Simplify® Cervical Artificial Disc Orthopedic 09/18/2020 Extended Follow-up of IDE Subjects Completed
P200022  S003 NuVasive, Inc. Simplify Cervical Artificial Disc Orthopedic 04/01/2021 Extended f/u of the 2-Level Simplify Completed
P070009 OBTECH MEDICAL GMBH REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X Gastroenterology/
Urology		 09/28/2007 Realize PAS Completed
P130004 OCULAR THERAPEUTIX, INC. RESURE SEALANT Ophthalmic 01/08/2014 Clinical PAS Completed
Retrospective Analysis Study for Endophthalmitis Completed
P030028 OPHTEC BV ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) Ophthalmic 09/10/2004 Long Term Completed
ECD Study Completed
P200035 OrganOx Limited OrganOx metra System Gastroenterology/
Urology		 12/09/2021 WP01 Long-Term Follow-up PAS Completed
WP02 Cont Access Long-Term F/u PAS Terminated
P200021 Oticon Medical Neuro Cochlear Implant System Ear Nose & Throat 06/23/2021 New Enrollment Study Terminated
P000029 Palette Life Sciences DEFLUX INJECTABLE GEL Gastroenterology/
Urology		 09/24/2001 Deflux Long-Term Completed
P100014 Palette Life Sciences SOLESTA INJECTABLE GEL Gastroenterology/
Urology		 05/27/2011 Solesta - Long Term Study Completed
P070005 PATHFINDER CELL THERAPY INC. REPEL-CV BIORESORBABLE ADHESION BARRIER Cardiovascular 03/06/2009 REPEL CV Other
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 Nit-Occlud PDA PAS Completed
P180034 Philips Image Guided Therapy Corporation Tack Endovascular System (6F) Cardiovascular 04/11/2019 TOBA II Continued f/u Study Completed
P190027 Philips Image Guided Therapy Corporation (formerly Intact) Tack Endovascular System (4F, 1.5-4.5mm) Cardiovascular 04/10/2020 TOBA II BTK Continued Follow-up Study Completed
P170018 Physio-Control, Inc LIFEPAK® CR2 Defibrillator Cardiovascular 12/21/2018 OUS Post Market Evaluation Study Completed
P150039 Poseidon Medical Inc. TRYTON SIDE BRANCH STENT Cardiovascular 02/21/2017 TRYTON Side Branch Stent PIVOTAL RCT Completed
TRYTON Side Branch Stent EA Confirmatory Completed
TRYTON Side Branch New Enrollment Study Completed
P180002 Pulmonx Corporation Zephyr Endobronchial Valve System Anesthesiology 06/29/2018 LIBERATE Extension Study Completed
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology		 11/18/2011 Enhanced Surveillance Study Completed
Registry Study Completed
P030050 Q-Med AB SCULPTRA AND SCULPTRA AESTHETIC General &
Plastic Surgery		 08/03/2004 Long Term Registry Completed
P040024 Q-Med AB RESTYLANE INJECTABLE GEL General &
Plastic Surgery		 03/25/2005 Restylane Completed
P030050  S002 Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery		 07/28/2009 Pre Clinical PAS Completed
Clinical PAS Completed
P030050  S034 Q-Med AB Sculptra and Sculptra Aesthetic General &
Plastic Surgery		 11/23/2021 Sculptra HF PAS Completed
P160052 QIAGEN Inc PartoSure test Toxicology 04/11/2018 PartoSure PAS Other
H030003 RELIANTHEART INC. DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM Cardiovascular 02/25/2004 HeartAssist 5 Pediatric VAD Terminated
P000008 ReShape Lifesciences, Inc. LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology		 06/05/2001 HERO-002 Completed
P000008  S017 ReShape Lifesciences, Inc. LAP-BAND Gastroenterology/
Urology		 02/16/2011 LBMI-002 Completed
Apollo-001 Terminated
P130019 ReShape Lifesciences, Inc. MAESTRO RECHARGEABLE SYSTEM Gastroenterology/
Urology		 01/14/2015 Extended F/u of Premarket Cohort Completed
New Enrollment Study Terminated
P160001 ReShape Lifesciences, Inc. OBALON BALLOON SYSTEM Gastroenterology/
Urology		 09/08/2016 Obalon Balloon System PAS Completed
P160001  S003 ReShape Lifesciences, Inc. OBALON BALLOON SYSTEM Gastroenterology/
Urology		 04/25/2017 Obalon Balloon System PAS Completed
P160039 RESPICARDIA remede® System Anesthesiology 10/06/2017 Post-Approval Study Completed
P100020 Roche Molecular Systems, Inc. COBAS HPV TEST Microbiology 04/19/2011 MWP-HPV-159 Completed
P100020  S017 Roche Molecular Systems, Inc. COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS Microbiology 07/07/2016 COB-HPV-301 Post Approval Study Completed
P150034 RVO 2.0, Inc. (d.b.a. Optics Medical) Raindrop Near Vision Inlay Ophthalmic 06/29/2016 Post-Approval Study Other
Raindrop Near Vision Inlay New Enrollment Other
P050034 Samsara Vision Inc. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 Premarket Cohort IMT-002-LTME Completed
P080009 Scott Laboratories, Inc SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM Anesthesiology 05/03/2013 Open Label PAS of SEDASYS Syst User Resp Terminated
Open Label Post Market Registry in Clinical Practi Terminated
P160048 Senseonics, Incorporated EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 06/21/2018 Post-Approval Study Completed
P200039 Shockwave Medical, Inc. Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Cardiovascular 02/12/2021 New Enrollment PAS Registry Completed
DISRUPT CAD III Cont f/u Study Completed
P010039 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS SONOCUR BASIC SYSTEM Orthopedic 07/19/2002 Sonocur Terminated
P000057 Smith & Nephew, Inc. ASCENSION MCP Orthopedic 11/19/2001 Ascension MCPT Completed
P030022 Smith & Nephew, Inc. REFLECTION CERAMIC ACETABULAR SYSTEM Orthopedic 12/17/2004 Reflection Long Term Completed
P040033 Smith & Nephew, Inc. BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 UK Study Completed
P150030 Smith & Nephew, Inc. R3 DELTA CERAMIC HIP SYSTEM Orthopedic 10/17/2016 Long-Term F/u of EU patients PAS Completed
Short to Mid-Term f/u of New US Patients Completed
P040028 SPECTRA SCIENCE LUMA CERVICAL IMAGING SYSTEM Obstetrics/
Gynecology		 03/16/2006 LUMA Terminated
P130026 St. Jude Medical TACTICATH QUARTZ SET Cardiovascular 10/24/2014 TactiCath Quartz PAS Completed
P970030 St. Jude Medical, Inc. TORONTO SPV VALVE Cardiovascular 11/04/1997 PAS Completed
P030016 STAAR Surgical Company VISIAN ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 12/22/2005 Adverse Event Study Completed
Follow-up Study Completed
Axial Lengths Completed
P030016  S035 STAAR Surgical Company EVO/EVO+VISIAN Implantable Collamer Lens Ophthalmic 03/25/2022 CP19-01 PAS F/u of PMA Cohort Completed
CP22-01 Postmarket Evaluation of the EVO ICL Completed
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 Stelkast Surpass Active PAS Terminated
P090012 STRATA SKIN SCIENCES, INC. MELAFIND General &
Plastic Surgery		 11/01/2011 PAS of MelaFind Terminated
P170024 Stryker Neurovascular Surpass Streamline Flow Diverter Neurology 07/13/2018 SCENT Post-Approval Study Completed
P180031 Stryker Neurovascular Neuroform Atlas® Stent System Neurology 05/16/2019 ATLAS Study Completed
P210025 Surmodics, Inc. SurVeil Drug-Coated Balloon Cardiovascular 06/16/2023 TRANSCEND Continued Follow-up Study Completed
H100006 SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM (DPS) Anesthesiology 09/28/2011 NeuRx DPS Completed
P030011 SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) Cardiovascular 10/15/2004 Long Term Completed
P030011  S011 SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 INTERMACS Companion Completed
P140002 TERUMO MEDICAL CORPORATION MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM Cardiovascular 05/22/2015 OSPREY Extended f/u study Completed
P160049 The Spectranetics Corp. STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON Cardiovascular 07/26/2017 ILLUMINATE Continued Follow-Up Study Completed
P920014  S016 THORATEC CORP. THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) Cardiovascular 11/06/2002 Continued Access/Registry/IDE Completed
P870072  S027 THORATEC LABORATORIES CORP. THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) Cardiovascular 08/03/2004 Thoratec IVAD Completed
P870072  S037 THORATEC LABORATORIES CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 Thoratec TLC-ii portable Other
P070004 Tiger Aesthetics Medical, LLC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery		 03/09/2012 Post-Approval PMA Cohorts Study (PACS) Completed
Post-Approval Cont Access Study (PACAS) Completed
Focus Group Study Completed
Post-Approval Case-Control Studies(PACCS) Terminated
P020012 Tiger Aesthetics Medical, LLC. ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER General &
Plastic Surgery		 10/27/2006 Study P521-01 Completed
P980052 TMJ CONCEPTS TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS Dental 07/02/1999 Long term Completed
P100049 TORAX MEDICAL LINX REFLUX MANAGEMENT SYSTEM Gastroenterology/
Urology		 03/22/2012 Extended f/u of premarket cohort Completed
Enrollment Study Completed
H130006 TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM Gastroenterology/
Urology		 12/18/2015 HDE Post-Approval Study Completed
P160013 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology		 03/22/2018 INSPIRE Continuation PAS Completed
P160013  S002 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology		 05/31/2019 EXPAND Continuation PAS Completed
P200031 TransMedics, Inc. Organ Care System (OCS™) Liver Gastroenterology/
Urology		 09/28/2021 PROTECT Continuation PAS Completed
PROTECT CAP Continuation PAS Completed
P040050 UROPLASTY, LLC MACROPLASTIQUE IMPLANTS Gastroenterology/
Urology		 10/30/2006 5 year registry - ROSE Completed
Enhanced Surveillance Completed
P210001  S001 Ventana Medical Systems Inc (Roche Tissue Diagnostics) VENTANA MMR RxDx Panel Pathology 03/21/2022 KEYTRUDA PAS Completed
P180003 Veryan Medical Ltd. BioMimics 3D Vascular Stent System Cardiovascular 10/04/2018 MIMICS-2 Continued f/u Study Completed
P180010 W. L Gore & Associates, Inc Gore Carotid Stent Cardiovascular 11/01/2018 SCAFFOLD Continued f/u study Terminated
P040043 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 03/23/2005 Cohort Study Completed
Training Study Completed
P040043  S051 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 Comprehensive/Linked-Registry Based Surv Completed
TAG Post-Approval Study Terminated
P160004 W. L. GORE & ASSOCIATES, INC. GORE TIGRIS VASCULAR STENT Cardiovascular 07/27/2016 Continued F/u Study Completed
P160021 W. L. Gore & Associates, Inc. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS Cardiovascular 01/27/2017 VBX FLEX Continued f/u Study Completed
P200030 W. L. Gore and Associates, Inc. Gore Excluder Conformable AAA Endoprosthesis (CEXC) Cardiovascular 12/22/2020 Cont f/u of the IDE Study Subjects Completed
P020004 W.L. GORE & ASSOCIATES,INC EXCLUDER BIFURCATED ENDOPROSTHESIS Cardiovascular 11/06/2002 PAS Completed
P020004  S006 W.L. GORE & ASSOCIATES,INC EXCLUDER BIFURCATED ENDOPROTHESIS Cardiovascular 06/02/2004 Long Term Follow up Completed
P050006 W.L. GORE & ASSOCIATES,INC GORE HELEX SEPTAL OCCLUDER Cardiovascular 08/11/2006 GORE HELEX Completed
P040037  S050 W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE Cardiovascular 10/18/2013 Extended F/u 25cm Viabahn Endoprosthesis Completed
P040037  S060 W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE Cardiovascular 09/19/2014 RELINE Extended F/U Study Completed
New Enrollment Study Completed
P020004  S123 W.L. GORE & ASSOCIATES,INC GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS Cardiovascular 02/29/2016 Post-Approval Study Completed
P050006  S060 W.L. GORE & ASSOCIATES,INC GORE CARDIOFORM Septal Occluder Cardiovascular 03/30/2018 Continued f/u of IDE Cohort Completed
P050006  S071 W.L. GORE & ASSOCIATES,INC GORE Cardioform ASD Occluder Cardiovascular 05/28/2019 Continued F/u of the ASSURED Study Completed
P070016 WILLIAM COOK EUROPE APS ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM Cardiovascular 05/21/2008 Longterm PAS Terminated
P180001 WILLIAM COOK EUROPE APS Zenith Dissection Endovascular System Cardiovascular 12/31/2018 Continued f/u of pivotal study Completed
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology		 05/12/2017 Flourish Real-World Evidence PAS Completed
P110008 Xtant Medical Holdings, Inc. COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 Coflex Long-Term PAS Completed
H120003 XVIVO PERFUSION XPS WITH STEEN SOLUTION PERFUSATE Gastroenterology/
Urology		 08/12/2014 Long-Term Study Terminated
P110002 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Extended f/u of premarket cohort Completed
Retrieval Analysis Completed
P110009 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Long Term PAS Completed
Enhanced Surveillance System Completed
Retrieval Analysis Completed
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Trilogy PAS Terminated
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 Long Term Study Completed
P010030  S056 ZOLL MANUFACTURING CORPORATION LIFEVEST WEARABLE DEFIBRILLATOR Cardiovascular 12/17/2015 PMA Post-Approval Study Completed


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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