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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Name
Date Original
Protocol
Accepted
Study Status
P160030 ABBOTT DIABETES CARE INC. Freestyle Libre Flash Glucose Monitoring System Clinical Chemistry 09/27/2017 FreeStyle Libre Flash Glucose Monitoring 12/08/2017 Progress Adequate
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study 09/07/2007 Progress Inadequate
H070005 Abbott Medical THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER Cardiovascular 01/10/2017 AMPLATZER PIVSD Occluder PAS 04/13/2017 Progress Adequate
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 Comprehensive/Linked-Registry Based Surv 10/24/2013 Progress Adequate
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ABSORB IV Post-Approval Study Progress Adequate
P140003
S004
ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEMS Cardiovascular 04/07/2016 Impella AMI CS PAS 08/09/2016 Progress Adequate
P140003
S005
ABIOMED, INC. IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM Cardiovascular 04/07/2016 Impella PCCS PAS 08/09/2016 Progress Adequate
P140003
S008
ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEM Cardiovascular 12/01/2016 Impella PROTECTED PCI PAS cVAD Registry 08/22/2017 Progress Adequate
P170011 Abiomed, Inc. Impella RP System Cardiovascular 09/20/2017 Impella RP-RWE Eval and Reporting 09/20/2017 Progress Adequate
Impella RP Pediatric-RWE Eval and Report 09/20/2017 Progress Adequate
P140003 ABIOMED, INC. IMPELLA 2.5 System Cardiovascular 03/23/2015 New Enrollment Study 11/13/2015 Revised/Replaced Study
P160047 AEGEA MEDICAL , 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 Progress Adequate
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Post-Approval Clinical Study 06/11/2015 Progress Adequate
Enhanced Safety Surveillance Study 06/11/2015 Progress Adequate
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 CyPass Micro Stent New Enrollment PAS 03/15/2017 Progress Adequate
COMPASS Extenstion Study 11/03/2016 Progress Adequate
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 10/11/2018 Study Pending
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 Natrelle and 410 Combined Cohort 02/20/2013 Progress Adequate
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 BIFS (Large PAS) 11/17/2006 Revised/Replaced Study
Natrelle and 410 Combined Cohort 08/03/2015 Progress Adequate
Re-Op Phase 01/16/2015 Progress Adequate
P930016
S053
AMO Manufacturing USA, LLC iDESIGNRefractive Studio, STAR Excimer Laser System Ophthalmic 06/15/2018 Post-Approval Study Protocol Pending
P150009 ANGEL MEDICAL SYSTEMS INC. ANGELMED GUARDIAN SYSTEM Cardiovascular 04/09/2018 AngelMed Guardian PAS 08/14/2018 Study Pending
P000008 APOLLO ENDOSURGERY INC LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology
06/05/2001 Lap-Band Long Term 06/05/2001 Revised/Replaced Study
P140008 APOLLO ENDOSURGERY INC ORBERA INTRAGASTRIC BALLOON Gastroenterology/
Urology
08/05/2015 ORBERA PAS (OPAS-001) 02/26/2016 Progress Adequate
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology
06/14/2016 PATHWAY Clinical Trial PAS Progress Adequate
AspireAssist Post-Approval Study 12/15/2016 Progress Inadequate
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 AtriCure Synergy Ablation System 12/14/2011 Progress Adequate
P070014
S010
BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 CONTINUUM Long Lesion PAS 12/23/2010 Progress Inadequate
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 CONTINUUM PAS 02/13/2009 Progress Inadequate
P070014
S037
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 Popliteal Indication PAS Surv Project 08/31/2016 Progress Adequate
P070014
S022
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 LifeStent SOLO PAS 09/16/2011 Progress Inadequate
P160024 BARD PERIPHERAL VASCULAR, INC. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT Cardiovascular 04/24/2017 BOLSTER Continued f/u Study Progress Adequate
P030002
S027
Bausch & Lomb, Inc. TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 New Enrollment Study 05/20/2013 Progress Adequate
P020014
S041
BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/29/2015 Post Approval Study 07/29/2015 Progress Adequate
P020014
S017
BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
02/24/2012 Essure/post-NovaSure PAS 02/24/2012 Progress Adequate
P160037 BECTON, DICKINSON AND COMPANY BD ONCLARITY HPV ASSAY Microbiology 02/12/2018 BD-USLHPV Post-Approval Study Study Pending
P160035 Berlin Heart Inc. EXCOR Pediatric Ventricular Assist Device Cardiovascular 06/06/2017 Berlin Heart Comprehensive Reg Based Surv 05/21/2018 Study Pending
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 Long Term PAS 04/21/2004 Progress Adequate
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 Extended f/u of Premarket Cohort 03/16/2016 Progress Adequate
P100006
S005
BIOMIMETIC THERAPEUTICS,LLC AUGMENT INJECTABLE Orthopedic 06/12/2018 Long-term PAS Study Pending
P030031
S011
BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 Atrial Fibrillation Registry 08/12/2009 Progress Adequate
CABANA Trial 11/24/2009 Progress Adequate
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 05/12/2008 Progress Adequate
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 07/03/2014 Progress Adequate
P980023
S057
BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P070008
S079
BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/ Quad LV Study Pending
P050023
S107
BIOTRONIK, INC. Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization Cardiovascular 05/06/2017 MPP QP-ExCELs Sub-Study PAS Progress Adequate
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 Progress Adequate
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 06/16/2016 Progress Adequate
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 08/01/2016 Progress Adequate
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 07/21/2017 Progress Adequate
P160003 BIOTRONIK, INC. PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM Cardiovascular 02/14/2017 Extended Study of Premarket Cohort Progress Adequate
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 Relay Thoracic Stent-Graft w Plus Del Sys 09/21/2012 Progress Adequate
P910073
S077
BOSTON SCIENTIFIC ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES Cardiovascular 11/10/2010 Longitudinal Surveillance Study 11/10/2010 Progress Adequate
P960040
S198
BOSTON SCIENTIFIC TELIGEN 4-SITE MODELS Cardiovascular 11/10/2010 Longitudinal Surveillance Study 11/10/2010 Progress Adequate
P960040
S385
BOSTON SCIENTIFIC NG4 Family of Pulse Generators ICDS. Cardiovascular 05/02/2017 MANAGE-HF 07/25/2017 Progress Adequate
SMART-MSP PAS 08/07/2017 Progress Adequate
P910073
S145
BOSTON SCIENTIFIC Reliance 4- Front Lead Family and Suture Sleeve Accessory Cardiovascular 05/04/2018 NAVIGATE X4 PAS Progress Adequate
P180011 Boston Scientific Corp. Eluvia Drug-Eluting Vascular Stent System Cardiovascular 09/18/2018 IMPERIAL Continued f/u study 09/18/2018 Study Pending
REGAL and EMINENT Long Term f/u studies 09/18/2018 Study Pending
P010012
S436
Boston Scientific Corp. NG4 Family of Pulse Generators CRT-DS Cardiovascular 05/02/2017 MANAGE-HF 07/25/2017 Progress Adequate
SMART-MSP PAS 08/07/2017 Progress Adequate
P150005
S014
Boston Scientific Corp. Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter Cardiovascular 12/21/2017 Zero-AF PAS 11/01/2018 Study Pending
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 ACUITY X4 Post Approval Study 02/22/2016 Progress Adequate
P010012
S212
Boston Scientific Corp. COGNIS 4-SITE MODELS Cardiovascular 11/10/2010 Longitudinal Surveillance Study 11/10/2010 Progress Adequate
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 New Patient Study 04/27/2010 Progress Adequate
P010012
S230
Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 MADIT-CRT ACC NCDR 09/16/2010 Progress Adequate
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 Fatigue & Stability Testing 10/10/2008 Progress Adequate
P110010
S001
Boston Scientific Corp. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 06/01/2012 PROMUS Element Plus US PAS 06/01/2012 Progress Adequate
P110010 Boston Scientific Corp. PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 11/22/2011 PROMUS Element Plus US PAS 11/22/2011 Progress Adequate
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 WATCHMAN Comprehensive/Linked-Registry 03/18/2016 Progress Adequate
Continued f/u of IDE Cohorts Progress Adequate
WATCHMAN New Enrollment (NESTed-PAS) 11/21/2016 Revised/Replaced Study
P150003 BOSTON SCIENTIFIC CORPORATION SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 10/02/2015 EVOLVE Short DAPT Stu;dy Progress Adequate
P110042 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 S-ICD PAS Registry 09/28/2012 Progress Adequate
P110042
S058
BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 08/08/2016 EMBLEM MRI S-ICD Pt Mgmt System Surv PAS Progress Adequate
P110042
S077
BOSTON SCIENTIFIC CORPORATION Model 3501 EMBLEM S-ICD subcutaneous Electrode Cardiovascular 09/29/2017 EMBLEM S-ICD Electrode Model 3501 PAS Progress Adequate
P150012 BOSTONSCIENTIFIC IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD Cardiovascular 04/25/2016 INGEVITY and SAMURAI Progress Adequate
P170042 C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 07/30/2018 AVeVA Continued F/U Post-Approval Study Study Pending
P150026
S002
CARDIOFOCUS, INC. Heart Light Catheter with Excalibur Balloon Cardiovascular 05/02/2018 CF HeartLight PAS Study Pending
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 PAS of HeartLight Endoscopic Ablation Sys Progress Inadequate
P150040
S003
Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser Ophthalmic 10/04/2018 VisuMax SMILE New Enrollment Protocol Pending
P150017 Cartiva, Inc CARTIVA SYNTHETIC CARTILAGE IMPLANT Orthopedic 07/01/2016 MOTION Extend Study Progress Adequate
P160014 CELONOVA BIOSCIENCES, INC. COBRA PzF NanoCoated Coronary Stent System Cardiovascular 02/21/2017 Cont f/u of PzF SHIELD IDE Cohort Progress Adequate
P070001 Centinel Spine, LLC PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 Long Term Study 12/17/2007 Progress Adequate
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 Post-Approval Study 03/17/2016 Progress Adequate
P170039 Clinical Research Consultants, Inc. CustomFlex Artificial Iris Ophthalmic 05/30/2018 PAS, Adult and Pediatric Protocol Pending
Pediatric New Enrollment Protocol Overdue
P130016 Cochlear Americas NUCLEUS HYBRID L24 IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 Extended f/u study 03/20/2014 Progress Adequate
New Enrollment Study 03/20/2014 Progress Adequate
P890055
S026
CODMAN CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 Leachables Study 12/17/2010 Progress Adequate
Drug Stability Study 12/17/2010 Progress Adequate
P100022 COOK MEDICAL INCORPORATED ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 New US Enrollment 11/14/2012 Progress Adequate
Zilver PTX Stent PAS 11/14/2012 Progress Adequate
P140016 COOK MEDICAL INCORPORATED ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT Cardiovascular 09/15/2015 Post-Approval Study Progress Adequate
P020018
S040
COOK, INC. ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 Long Term F/U Study 04/04/2012 Progress Adequate
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 Long Term Study 07/03/2007 Progress Adequate
P120023 CorneaGen KAMRA INLAY Ophthalmic 04/17/2015 New Enrollment Study 05/12/2016 Protocol Overdue
P070026
S004
DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 Short-Mid-Term F/u of New COC36 patients 04/02/2013 Progress Adequate
COC36 PAS: UK & Australian Natl Joint Reg 04/02/2013 Progress Adequate
Long-Term F/U of IDE COC36 patients 04/02/2013 Progress Adequate
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Duraloc Long Term 05/03/2005 Revised/Replaced Study
P070026 DEPUY ORTHOPAEDICS, INC. CERAMAX CERAMIC HIP SYSTEM Orthopedic 12/23/2010 Ceramax PAS 12/23/2010 Progress Inadequate
P120005
S041
DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 12/20/2016 Dexcom G5 Mobile Cont Glucose Monitoring Sys -PAS 12/20/2016 Progress Adequate
P110014 DUNE MEDICAL DEVICES INC DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery
12/27/2012 MarginProbe System US PAS 12/27/2012 Progress Adequate
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) 06/16/2014 Progress Adequate
Comprehensive/Linked-Registry Based Surv 06/16/2014 Progress Adequate
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 Continued f/u of premarket cohort 06/17/2015 Progress Adequate
Comprehensive/Linked-Registry Progress Adequate
P860057
S042
EDWARDS LIFESCIENCES, LLC. CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 05/07/2009 Clinical Study 11/03/2009 Progress Adequate
P860057
S029
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term 12/05/2008 Progress Adequate
P150048 EDWARDS LIFESCIENCES, LLC. EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) Cardiovascular 06/29/2017 Model 11500A Prospective PAS 01/08/2018 Study Pending
PAS Continued Follow-up 07/29/2017 Progress Adequate
P130009
S057
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P140031
S010
EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort 07/23/2018 Study Pending
Comprehensive/Linked-Registry Based Surv Progress Adequate
P130009
S034
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 Continued f/u of the premarket cohort 10/09/2015 Progress Adequate
Comprehensive Linked Registry-Based Surv Progress Adequate
P130009
S037
EDWARDS LIFESCIENCES, LLC. SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 02/29/2016 COMPASSION Cohort Progress Adequate
New Enrollment SAPIEN XT Pulmonic PAS 09/20/2016 Progress Adequate
P150048
S012
EDWARDS LIFESCIENCES, LLC. Edwards Pericardial Mitral Bioprosthesis, Model 11000M Cardiovascular 08/09/2018 Model 11000M, Continued f/u Post-Approval Study 11/05/2018 Study Pending
P140031
S028
EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/05/2017 SAPIEN 3 Mitral Valve-in-Valve Comp Surv 11/20/2017 Progress Adequate
SAPIEN 3 Aortic Valve-in-Valve Comp Surv 11/20/2017 Progress Adequate
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 New Enrollment 03/17/2010 Revised/Replaced Study
Esteem New Enrollment 2 04/16/2010 Progress Inadequate
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 Epi proColon PAS 10/18/2016 Progress Adequate
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 Cologuard PAS 02/02/2015 Progress Adequate
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Novation PAS 07/05/2007 Progress Adequate
Long Term 07/05/2007 Revised/Replaced Study
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 Prometra Programmable Pump system 05/03/2012 Progress Inadequate
Extended Use Stability Study 05/04/2012 Progress Adequate
Leachables Study 05/04/2012 Progress Adequate
P170043 Glaukos Corporation iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) Ophthalmic 06/21/2018 Extended f/u Premarket Cohort Protocol Pending
New Enrollment PAS Protocol Pending
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 New Enrollment Study 06/25/2012 Progress Inadequate
Registry Study 06/25/2012 Revised/Replaced Study
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Enhanced Surveillance 09/28/2012 Progress Adequate
P950039
S026
HOLOGIC, INC. THINPREP-5000 Pathology 03/02/2015 ThinPrep 5000-Post-Approval Study Progress Adequate
P010013
S041
HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
02/01/2013 NovaSure PAS 02/01/2013 Progress Inadequate
P120011 IDEALIMPLANT IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT General &
Plastic Surgery
11/14/2014 Post-Approval PMA Cohort Study (PACS) 11/14/2014 Progress Adequate
P110039 InSightec EXABLATE General &
Plastic Surgery
10/18/2012 New Enrollment Study 10/18/2012 Progress Adequate
P150038 InSightec EXABLATE Neurology 07/11/2016 Long Term PAS 09/29/2016 Progress Adequate
P040003
S015
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
08/31/2015 Post ExAblate Pregnancy Outcomes Registry 08/31/2015 Progress Inadequate
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 New Enrollment Study 04/30/2014 Progress Inadequate
P000057 INTEGRA LIFESCIENCES CORPORATION ASCENSION MCP Orthopedic 11/19/2001 Ascension MCPT 11/19/2001 Progress Adequate
P170034 Ivantis, Inc. HYDRUS MICROSTENT Ophthalmic 08/10/2018 Continuation of Premarket Cohort PAS Protocol Pending
Modified Hydrus New Enrollment PAS Protocol Pending
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 07/31/2015 Progress Adequate
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 07/10/2018 Study Pending
P980040
S039
Johnson & Johnson Surgical Vision, Inc. TECNIS TORIC 1-PEICE INTRAOCULAR LENS Ophthalmic 04/15/2013 New Enrollment of Post Approval Study 04/15/2013 Progress Adequate
H130001 KANEKA PHARMA AMERICA LLC KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN Gastroenterology/
Urology
03/05/2015 New Enrollment Study 08/24/2015 Progress Inadequate
H120005 KANEKA PHARMA AMERICA LLC LIPOSORBER LA-15 SYSTEM Gastroenterology/
Urology
10/10/2013 New Enroll. PAS for Liposorber LA-15 Sys 10/10/2013 Progress Inadequate
H170002 Kaneka Pharma America LLC LIPOSORBER LA-15 System Gastroenterology/
Urology
03/20/2018 New Enroll PAS LIPOSORBER LA-15 Adults Protocol Pending
P110002 LDR Spine USA MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Enhanced Surveillance System 05/16/2014 Progress Adequate
Retrieval Analysis 07/15/2014 Progress Adequate
P110009 LDR SPINE USA INC. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Enhanced Surveillance System 08/23/2013 Progress Adequate
Retrieval Analysis 08/23/2013 Progress Adequate
P060038
S017
LivaNova Canada Corp. MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL Cardiovascular 04/18/2014 NEMO PAS 07/15/2014 Progress Adequate
P130024 LUTONIX LUTONIX DRUG COATED BALLOON PTA CATETER Cardiovascular 10/09/2014 PAS 1 (Extended Follow-up Study) 10/09/2014 Progress Adequate
PAS 2 (New Enroll. of Female Pat. Study) 10/09/2014 Progress Adequate
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 IDE Cohort Post Approval Study Progress Adequate
New Enrollment PAS Registry 02/26/2018 Progress Adequate
P130024
S009
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P130021
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MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 Continued f/u of the premarket cohorts 06/12/2014 Progress Adequate
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P080006
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MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD Cardiovascular 04/01/2011 Chronic Lead Performance 04/01/2011 Progress Adequate
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P100040
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P890003
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11/17/2006 MemoryGel and Shape Glow Study 10/01/2014 Progress Adequate
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06/14/2013 MemoryGel and Shape Glow Study 06/14/2013 Progress Adequate
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MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
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Autopsy Study 11/14/2013 Progress Adequate
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NUMED, INC. Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) Cardiovascular 10/24/2017 PARCS continued f/u survey 10/24/2017 Study Pending
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P160001
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11/18/2011 Registry Study 11/18/2011 Progress Inadequate
Deep Hyperthermia and Radiation 11/18/2011 Revised/Replaced Study
Enhanced Surveillance Study 11/18/2011 Progress Inadequate
P030050
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Q-Med AB SCULPTRA AESTHETIC General &
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P140012 ReShape Lifesciences, Inc. RESHAPE INTEGRATED DUAL BALLOON SYSTEM Gastroenterology/
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Ext f/u of the Argus II Feasibility Study 02/13/2013 Progress Adequate
P160048 SENSEONICS, INCORPORATED EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 06/21/2018 Post-Approval Study 09/18/2018 Study Pending
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St. Jude Medical, Inc. OPTISURE Cardiovascular 02/21/2014 OptiSure Lead Post Approval Study 02/21/2014 Progress Adequate
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St. Jude Medical, Inc. SJM Masters Series Mechanical Heart Valve, 15mm HP Cardiovascular 03/06/2018 Cont f/u of the premarket HALO Cohort Study Pending
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P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 Long term 05/12/2006 Revised/Replaced Study
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SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 INTERMACS Companion 05/16/2012 Progress Adequate
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Thoratec Corporation HeartMate 3 Left Ventricular Assist System Cardiovascular 10/18/2018 Continued f/u of Premarket Pivotal Cohort Protocol Pending
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W.L. GORE & ASSOCIATES,INC GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS Cardiovascular 02/29/2016 Post-Approval Study 02/29/2016 Progress Adequate
P040037
S060
W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE Cardiovascular 09/19/2014 New Enrollment Study 04/03/2015 Progress Adequate
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 11/26/2008 Progress Adequate
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology
05/12/2017 Flourish Post-Approval Study 04/27/2018 Progress Adequate
H120003 XVIVO PERFUSION XPS WITH STEEN SOLUTION PERFUSATE Gastroenterology/
Urology
08/12/2014 Long-Term Study 04/10/2015 Progress Adequate
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 Long Term Study 11/06/2008 Progress Inadequate
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Long term 06/28/2006 Revised/Replaced Study
P160022 ZOLL MEDICAL CORPORATION X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Battery Pack, SurePower II™ Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3™ Battery Pack, SurePower™ Charger, and SurePower™ Single Bay Charger Cardiovascular 12/27/2017 Reconfirmation Analysis Mode Algorithm PAS Study Pending


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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