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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
P000039 Abbott Medical THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM Cardiovascular 12/05/2001 Long term 12/05/2001 Completed
P020024 Abbott Medical AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM Cardiovascular 05/14/2003 Long term 05/14/2003 Completed
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 5 year long term (IDE) 09/07/2007 Terminated
P020024
S037
Abbott Medical AMPLATZER DUCT OCCLUDER II Cardiovascular 08/18/2013 Continued F/u of the Premarket ADO II PAS 08/18/2013 Completed
P040012
S034
ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM Cardiovascular 05/06/2011 CANOPY Trial 05/06/2011 Completed
P110001 ABBOTT VASCULAR RX HERCULINK ELITE RENAL STENT SYSTEM Cardiovascular 07/20/2011 HERCULES PAS 06/26/2012 Completed
P110019 ABBOTT VASCULAR XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 11/01/2011 XIENCE PRIME and XIENCE PRIME LL Everolimus Elut 10/27/2011 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 10/03/2014 Completed
P120020 ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) SUPERA PERIPHERAL STENT SYSTEM Cardiovascular 03/28/2014 SUPERB Extended F/U Study 03/28/2014 Completed
P040038 ABBOTT VASCULAR INC. XACT CAROTID STENT SYSTEM Cardiovascular 09/06/2005 EXACT Study 10/12/2005 Completed
PROTECT Study 02/05/2007 Completed
P070015 ABBOTT VASCULAR INC. XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS Cardiovascular 07/02/2008 Fatigue Testing 07/02/2008 Completed
Longterm IDE Follow up 07/02/2008 Completed
XIENCE Registry 07/02/2008 Completed
Dual Antiplatelet Therapy 07/02/2008 Completed
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 New EnrollMitraClip Analysis Cohort (MAC) 10/24/2013 Completed
P070015
S054
ABBOTT VASCULAR INC. XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 05/24/2011 SPIRIT Small Vessel (SV) Registry 05/24/2011 Completed
P070015
S122
ABBOTT VASCULAR INC. XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 Extended followup of the EXPERT CTO Study 10/03/2014 Completed
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ABSORB USA Post Approval Clinical Study Other
H040006 ABIOMED, INC. ABIOCOR IMPLANTABLE REPLACEMENT HEART Cardiovascular 09/05/2006 Abiocor Artificial Heart 09/05/2006 Other
H140001 ABIOMED, INC. IMPELLA RP SYSTEM Cardiovascular 01/23/2015 Impella RP Prospective Study 01/23/2015 Terminated
Impella RP Pediatric Study 01/23/2015 Terminated
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 Completed
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Post-Approval Clinical Study 06/11/2015 Completed
P930014
S045
ALCON LABORATORIES, INC. ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL Ophthalmic 05/03/2011 New Enrollment PAS 05/03/2011 Completed
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 COMPASS Extension Study 11/03/2016 Completed
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 Focus Group 11/17/2006 Completed
Core 11/17/2006 Completed
Informed Decision Process 10/17/2006 Completed
Adjunct 11/17/2006 Completed
Device failure Study 11/17/2006 Other
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 Core Study 02/20/2013 Completed
Continued Access Study (Natrelle 410 CAS) 02/20/2013 Completed
Case Control Studies 08/03/2012 Terminated
Focus Group Study 02/20/2013 Completed
P110033 Allergan JUVEDERM VOLUMA XC General &
Plastic Surgery
10/22/2013 VOLUMA-003 Repeat Treatment Study 10/22/2013 Completed
P900030 Allergan, Inc. CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT Gastroenterology/
Urology
09/30/1993 Long term Cohort C 09/30/1993 Completed
P930016
S025
AMO Manufacturing USA, LLC STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM Ophthalmic 07/11/2007 Star 4 Monovision Lasik 07/11/2007 Other
P050033 Anika Therapeutics, Inc. HYDRELLE General &
Plastic Surgery
12/20/2006 Elevess CTA Study 04/29/2008 Completed
P140012 Apollo Endosurgery RESHAPE INTEGRATED DUAL BALLOON SYSTEM Gastroenterology/
Urology
07/28/2015 REDUCE PAS 01/14/2016 Terminated
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology
06/14/2016 PATHWAY Clinical Trial PAS Completed
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 AtriCure Synergy Ablation System 12/14/2011 Completed
P940016 B. Braun Avitum AG H.E.L.P. SYSTEM Gastroenterology/
Urology
09/19/1997 Registry 09/19/1997 Completed
P060002 BARD PERIPHERAL VASCULAR FLAIR ENDOVASCULAR STENT GRAFT Cardiovascular 07/23/2007 FLAIR Endovascular Grafts 03/13/2008 Completed
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 RESILIENT 02/13/2009 Completed
CONTINUUM PAS 02/13/2009 Terminated
P070014
S010
BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 CONTINUUM Long Lesion PAS 12/23/2010 Terminated
P070014
S022
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 LifeStent SOLO PAS 09/16/2011 Terminated
P160024 BARD PERIPHERAL VASCULAR, INC. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT Cardiovascular 04/24/2017 BOLSTER Continued f/u Study Completed
P180024 BAROnova, Inc TransPyloric Shuttle/TransPyloric Shuttle Delivery Device Gastroenterology/
Urology
04/16/2019 ENDObesity PAS 04/16/2019 Other
P010062 BAUSCH & LOMB EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR Ophthalmic 06/07/2004 Long term 06/07/2007 Completed
P980006
S004
Bausch & Lomb, Inc. PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES Ophthalmic 11/20/2001 Long Term 11/20/2001 Completed
P830063
S002
BAXTER INTERNATIONAL, INC. GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N Gastroenterology/
Urology
08/28/2002 Gambro PAS 08/28/2002 Completed
P020014 BAYER PHARMA AG ESSURE SYSTEM Obstetrics/
Gynecology
11/04/2002 5 year follow up 11/04/2002 Completed
Newly Trained Physicians 11/04/2002 Completed
P020014
S006
BAYER PHARMA AG ESSURE SYSTEM Obstetrics/
Gynecology
07/22/2004 HSG Evaluation Study 07/22/2004 Completed
P020014
S012
BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/15/2007 ESS-305 06/15/2007 Completed
P970018
S033
BD Diagnostic Systems BD SUREPATH COLLECTION VIAL Pathology 12/02/2016 BD SurePath Collection Vial-Post-Approval Study 12/02/2016 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 12/16/2011 Terminated
P000018 BEST VASCULAR, INC BETA-CATH (TM) SYSTEM Cardiovascular 11/03/2000 Beta-Cath Long Term 11/03/2000 Terminated
P020016 BIOMET MICROFIXATION, INC. WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM Dental 09/21/2005 Longterm Followup Study 09/21/2005 Completed
P050009 Biomet, Inc. C2 A-TAPER ACETABULAR SYSTEM Orthopedic 12/16/2005 Long Term Study 12/16/2005 Terminated
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 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 12/19/2005 Completed
P040036 BIOSENSE WEBSTER, INC. NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER Cardiovascular 08/11/2006 NaviStar Study 08/11/2006 Completed
P030031
S011
BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 CABANA Trial 11/24/2009 Completed
Atrial Fibrillation Registry 08/12/2009 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) 08/10/2006 Completed
TUPOS LV 08/10/2006 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 05/12/2008 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 06/16/2016 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 08/01/2016 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 07/21/2017 Completed
P160025 BIOTRONIK, INC. ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM Cardiovascular 03/23/2017 BIOFLEX-I PAS 03/23/2017 Completed
P940008 BOSTON SCIENTIFIC RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS Cardiovascular 11/28/1995 PAS 11/28/1995 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 10/12/2006 Completed
SONOMA 10/12/2006 Other
P830060
S062
BOSTON SCIENTIFIC LEAD TUNNELER MODEL 6888 Cardiovascular 11/10/2010 Longitudinal Surveillance Study 01/14/2011 Terminated
P980003 Boston Scientific Corp. CHILLI COOLED RF ABLATION SYSTEM Cardiovascular 02/02/1999 PAS 02/02/1999 Completed
P920023 Boston Scientific Corp. UROLUME ENDOPROSTHESIS Gastroenterology/
Urology
05/06/1996 Urolume PAS 05/06/1996 Completed
P030025 Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 03/04/2004 ARRIVE I 03/04/2004 Completed
TAXUS (IDE) 03/04/2004 Completed
P020006 Boston Scientific Corp. ENTERYX PROCEDURE KIT Gastroenterology/
Urology
04/22/2003 Enteryx 12/27/2007 Terminated
P000053
S005
Boston Scientific Corp. SPHINCTER 800 URINARY CONTROL SYSTEM Gastroenterology/
Urology
10/13/2006 Registry AMS MC-0611 02/07/2007 Completed
P050019 Boston Scientific Corp. CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS Cardiovascular 10/23/2008 BEACH STUDY 10/23/2008 Completed
CABANA REGISTRY 10/23/2008 Completed
P050024 Boston Scientific Corp. CRYOCOR CRYOABLATION SYSTEM Cardiovascular 08/01/2007 Cryocor Ablation PAS 03/13/2008 Terminated
P030025
S021
Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM Cardiovascular 09/24/2008 5 year clinical outcomes 09/24/2008 Completed
Fatigue/Matter Testing 09/24/2008 Completed
P060006 Boston Scientific Corp. BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM Cardiovascular 12/11/2008 BSC Express PAS 12/11/2008 Completed
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 Outcomes TAXUS ATLAS 10/10/2008 Completed
Dual Antiplatelet Study 06/28/2010 Completed
TAXUS Registry 10/10/2008 Completed
P030025
S028
Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) Cardiovascular 09/24/2008 Fatigue/Matter Testing 09/24/2008 Completed
5 year Clinical Outcomes 09/24/2008 Completed
P010012
S160
Boston Scientific Corp. ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 Cardiovascular 05/16/2008 ACUITY Long-Term Registry 05/16/2008 Completed
P060008
S008
Boston Scientific Corp. TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 05/21/2009 TAXUS ATLAS Small Vessel 07/23/2009 Completed
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 AIR2 - Extended Study 07/27/2010 Completed
P060008
S011
Boston Scientific Corp. TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 07/13/2009 TAXUS Long (S011) 07/23/2010 Completed
P000040
S014
Boston Scientific Corp. GENESYS HTA SYSTEM Obstetrics/
Gynecology
04/23/2010 Genesys HTA Post Approval Registry 04/23/2012 Completed
P010012
S230
Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 MADIT-CRT Registry 09/27/2011 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) 04/22/2011 Completed
ION Post Approval Study 04/22/2011 Completed
P110010 Boston Scientific Corp. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 11/22/2011 PROMUS Element Plus US PAS 11/22/2011 Completed
Continued F/u of Premarket Cohort 11/22/2011 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 06/01/2012 Completed
Continued F/U of Premarket Cohort 06/01/2012 Completed
P140028 BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM Cardiovascular 07/21/2015 SuperNOVA Continued f/u 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
P140004 Boston Scientific Neuromodulation SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 SPACER 11/18/2015 Completed
P040016 BOSTON SCIENTIFIC SCIMED, INC. VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM Cardiovascular 04/12/2005 Longterm Outcomes 04/12/2005 Completed
P030030 C.R. Bard, Inc. URYX URETHRAL BULKING AGENT Gastroenterology/
Urology
12/16/2004 Tegress PAS 12/16/2004 Terminated
P150017 Cartiva, Inc CARTIVA SYNTHETIC CARTILAGE IMPLANT Orthopedic 07/01/2016 MOTION Extend Study Completed
P050010 Centinel Spine, LLC PRODISC -L TOTAL DISC REPLACEMENT DEVICE Orthopedic 08/14/2006 PRODISC-L Long Term Study 08/14/2006 Completed
P070001 Centinel Spine, LLC PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 Long Term Study 12/17/2007 Completed
Enhanced Surveillance Study 08/12/2008 Completed
P010001 CERAMTEC GMBH CERAMIC TRANSCEND HIP ARTICULATION SYSTEM Orthopedic 02/03/2003 Ceramic Transcend Hip 02/03/2003 Completed
P970051
S028
Cochlear Americas NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/01/2005 Adult Study 03/01/2005 Completed
Pediatric Study 03/01/2005 Completed
P070013 COLBAR LIFESCIENCE LTD. EVOLENCE COLLAGEN FILLER General &
Plastic Surgery
06/27/2008 EVOLENCE 09/15/2008 Terminated
P000006 COLOPLAST CORP. TITAN INFLATABLE PENILE PROSTHESIS Gastroenterology/
Urology
07/14/2000 Coloplast PAS 07/14/2000 Completed
P100022 Cook Ireland, Ltd. ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 New US Enrollment 11/14/2012 Completed
P100028 COOK MEDICAL INCORPORATED FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM Cardiovascular 01/14/2011 REFORM 12/05/2011 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 06/09/2005 Completed
P020018
S010
COOK, INC. 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT Cardiovascular 09/07/2006 AAA Flex 36mm 09/07/2006 Completed
P020018
S040
COOK, INC. ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 Training Program 04/04/2012 Completed
P000032
S028
CooperSurgical, Inc. HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM Obstetrics/
Gynecology
03/27/2009 Her Option PAS 03/27/2009 Completed
P990036 CORDIS CORP. CORDIS CHECKMATE(TM) SYSTEM Cardiovascular 11/03/2000 PAS 11/03/2000 Completed
P030047 CORDIS CORP. CORDIS PRECISE NITINOL STENT SYSTEM Cardiovascular 09/22/2006 Longterm & CASES Studies 09/22/2006 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 04/24/2003 Completed
P020026
S017
CORDIS CORP. RAPTORRAIL RX SDS, 2.25MM CYPHER STENT Cardiovascular 09/18/2009 CYPHER MINI 08/17/2009 Completed
P120002 CORDIS CORP. SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS Cardiovascular 11/07/2012 STROLL Post Approval Study 11/07/2012 Completed
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 New Enrollment 07/03/2007 Completed
Long Term Study 07/03/2007 Completed
P120023 CorneaGen KAMRA INLAY Ophthalmic 04/17/2015 New Enrollment Study 05/12/2016 Other
Continuation Study Completed
P970029 CRYOLIFE, INC. TMR HOLMIUM LASER SYSTEM Cardiovascular 02/11/1999 TMR 10/20/2009 Completed
P970029
S014
CRYOLIFE, INC. CARDIOGENESIS HOLMIUM TMR SYSTEM Cardiovascular 02/22/2012 PEARL 8.0 New Enrollment Study 02/22/2012 Other
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Kaiser Permanente Joint Registry 04/20/2010 Terminated
Natl Joint Registry for England and Wales 04/20/2010 Terminated
Australian Ortho Assc Natl Joint Registry 04/20/2010 Terminated
New England Bapt Hospital Joint Registry 05/03/2005 Terminated
Prospective Post-Approval Study 04/20/2010 Terminated
DePuy Outcome Tracking Sys Registry(DOTS) 04/20/2010 Terminated
P090002 DEPUY ORTHOPAEDICS, INC. PINNACLE COMPLETE ACETABULAR HIP SYSTEM Orthopedic 06/13/2011 Pinnacle CoMplete Acetabular Hip System 11/04/2011 Terminated
P070026
S004
DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 Long-Term F/U of IDE COC36 patients 04/02/2013 Completed
COC36 PAS: UK & Australian Natl Joint Reg 04/02/2013 Completed
P040006 DEPUY SPINE,INC CHARITE ARTIFICIAL DISC Orthopedic 10/26/2004 Charite Artificial Disc 10/26/2004 Terminated
N980003 DJO SURGICAL KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM Orthopedic 11/26/2003 Encore Keramos PDP Study 11/26/2003 Completed
P110021 EDWARDS LIFESCIENCES LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/19/2012 Continue F/u of Premarket Cohort 10/19/2012 Completed
Newly Enrolled Study 10/19/2012 Completed
P870077 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS Cardiovascular 09/25/1991 PAS 09/25/1991 Completed
P010041 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) Cardiovascular 06/24/2002 Long term 06/24/2002 Completed
P860057
S016
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Cardiovascular 11/29/2001 PAS 11/29/2001 Completed
P010041
S002
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert 05/09/2003 Completed
P870077
S013
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert 05/09/2007 Completed
P000007
S003
EDWARDS LIFESCIENCES, LLC. EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert 05/09/2003 Completed
P860057
S019
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Cardiovascular 05/09/2003 PERIMOUNT Plus Pericardial Bioprosthesis Model 6900P 05/09/2003 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 08/22/2003 Completed
P860057
S018
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC Cardiovascular 11/14/2003 Perimount Magna Pericardial Bioprosthesis 11/14/2003 Completed
P860057
S023
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX Cardiovascular 04/07/2005 Carpentier Edwards PAS 04/07/2005 Completed
P100041 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 11/02/2011 Newly Enrolled Study 11/02/2011 Completed
Continue Follow-Up of Premarket Cohort 11/02/2011 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) 06/16/2014 Completed
H080005 ELANA INC. ELANA ARTERIOTOMY SYSTEM Neurology 03/10/2011 Elana Surgical KitHUD 03/10/2011 Other
P040002 ENDOLOGIX, INC. ENDOLOGIX POWERLINK SYSTEM Cardiovascular 10/29/2004 Long Term/Pivotal Cohort 10/29/2004 Completed
P120006 Endologix, Inc. OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 Training Program 10/05/2012 Completed
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 Extended Follow-up of PMA study 03/17/2010 Completed
P040029 Euclid Systems Corporation JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR Ophthalmic 09/29/2004 JSZ Orthokeratology Contact Lenses 09/29/2004 Completed
P030004 EV3 NEUROVASCULAR ONYX LIQUID EMBOLIC SYSTEM Neurology 07/21/2005 Long Term Study 07/21/2005 Completed
P100042 GEN-PROBE INCORPORATED APTIMA HPV ASSAY Microbiology 10/28/2011 APTIMA HPV Assay 10/28/2011 Completed
P120007 GEN-PROBE INCORPORATED APTIMA HPV 16 18/45 GENOTYPE ASSAY Microbiology 10/12/2012 HPVGTS-US-10-002 10/12/2012 Completed
P030032 GENZYME BIOSURGERY HYLAFORM (HYLAN B GEL) General &
Plastic Surgery
04/22/2004 Fitzpatrick skin types 04/22/2004 Completed
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 Extended F/u of IDE Cohort Study 06/25/2012 Completed
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Extended f/u of premarket cohort 09/28/2012 Completed
P970021
S014
GYNECARE, INC. GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM Obstetrics/
Gynecology
07/06/2007 Long-Term Study 01/29/2008 Completed
P040052 HOLOGIC, INC. MONOPREP PAP TEST Pathology 03/03/2006 CHOICE Study 12/18/2007 Other
SURE Study 10/18/2007 Completed
P070022 HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM Obstetrics/
Gynecology
07/06/2009 EASE TRIAL 07/06/2009 Terminated
P080014 HOLOGIC, INC. CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT Microbiology 03/12/2009 Cervista HPV HR Assay 03/12/2009 Completed
P080015 HOLOGIC, INC. CERVISTA HPV 16/18 Microbiology 03/12/2009 Cervista HPV HR Assay 03/12/2009 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 08/16/2003 Completed
P110039 InSightec EXABLATE General &
Plastic Surgery
10/18/2012 Enhanced Surveillance Registry Study 10/18/2012 Completed
P040003 INSIGHTEC, LTD EXABLATE 2000 SYSTEM Obstetrics/
Gynecology
10/22/2004 Long Term Exablate Study 10/22/2004 Completed
P040003
S006
INSIGHTEC, LTD EXABLATE 2100 SYSTEM Obstetrics/
Gynecology
12/22/2009 Exablate 2100 Type 1.0 04/19/2010 Completed
P040003
S016
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
10/05/2015 Study to Evaluate Safety of ExAblate 11/04/2015 Completed
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 Ext FU Premkt Cohort Inspire 4 STAR Trial 04/30/2014 Completed
P040034 INTEGRA LIFESCIENCES CORPORATION DURASEAL DURAL SEALANT SYSTEM Neurology 04/07/2005 Duraseal 04/07/2005 Completed
P080013 INTEGRA LIFESCIENCES CORPORATION DURASEAL EXACT SPINE SEALANT SYSTEM Neurology 09/04/2009 DuraSeal Exact Spine Sealant System 09/04/2009 Completed
P890055
S026
Intera Oncology CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 Long-Term Surveillance of MedStream 03/15/2011 Other
P160050 INTRINSIC THERAPEUTICS BARRICAID ANULAR CLOSURE DEVICE (ACD) Orthopedic 02/08/2019 Histological and Retrieval Analysis PAS Other
P060017 JANSSEN DIAGNOSTICS GENESEARCH BREAST LYMPH NODE(BLN) ASSAY Pathology 07/16/2007 PPC Study 10/29/2007 Other
TS Study 10/29/2007 Other
P950015 Laser Engineering Heart Inc. THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION Cardiovascular 08/20/1998 Heart Laser CO2 08/20/1998 Completed
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 Terminated
P970003
S050
LivaNova USA, Inc. VNS THERAPY SYSTEM Neurology 07/15/2005 Registry Study 07/15/2005 Completed
Dosing Study D-21 07/15/2005 Completed
P110032 Lombard Medical Limited AORFIX FLEXIBLE STENT GRAFT SYSTEM Cardiovascular 02/14/2013 Comprehensive/Linked-Registry Based Surv 06/06/2014 Other
Aorfix Post Approval Study 11/01/2013 Terminated
P130024 LUTONIX LUTONIX DRUG COATED BALLOON PTA CATETER Cardiovascular 10/09/2014 PAS 2 (New Enroll. of Female Pat. Study) 10/09/2014 Completed
PAS 1 (Extended Follow-up Study) 10/09/2014 Completed
P130024
S009
LUTONIX LUTONIX 035 DRUG COATED BALLOON PTA CATHETER Cardiovascular 02/07/2017 Lutonix Long Lesion SFA Cont f/u study Completed
ISR and LL Cohorts of the Global SFA Reg Completed
SFA ISR IDE Continued 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 08/25/2008 Completed
P040013
S016
Lynch Biologics LLC GEM 21S GROWTH FACTOR ENHANCED MATRIX Dental 05/27/2011 GEM21S Growth Factor 05/27/2011 Completed
P030006 MEDIFOCUS, INC PROLIEVE THERMODILATATION SYSTEM Gastroenterology/
Urology
02/19/2004 Prolieve PAS 02/19/2004 Completed
P110004 MEDINOL LTD. PRESILLION PLUS COCR CORONARY STENT RX SYSTEM Cardiovascular 04/12/2012 Continued f/u of BLAST Placebo Cohort 04/12/2012 Completed
Enrollment of New US Cohort 04/12/2012 Other
H160002 Medos International, SARL PulseRider Aneurysm Neck Reconstruction Device Neurology 06/19/2017 ANSWER Clinical Study Completed
P990046 MEDTRONIC ATS MEDICAL, INC. ATS OPEN PIVOT BILEAFLET HEART VALVE Cardiovascular 10/13/2000 Wear testing 04/24/2009 Completed
P010031
S104
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/INSYNC SENTRY/INSYNC MAXIMO Cardiovascular 08/28/2008 Enhanced Surveillance 08/28/2008 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 08/28/2008 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 01/09/2012 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 01/09/2012 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 09/25/2013 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 09/25/2013 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
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
P130021 MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 New Enrollment of extreme risk patients 01/17/2014 Terminated
P020045 Medtronic CryoCath LP 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM Cardiovascular 04/17/2003 CryoFACTS 04/17/2003 Completed
P100010 Medtronic CryoCath LP ARCTIC FRONT CRYOCATHETER SYSTEM Cardiovascular 12/17/2010 STOP AF PAS 12/17/2010 Completed
P950024 MEDTRONIC Inc. MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 Cardiovascular 09/06/1996 Unipolar Model 4965 09/06/1996 Completed
P960009 MEDTRONIC Inc. MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM Neurology 07/31/1997 Neurotoxicity/Carcinogenicity 04/16/2010 Completed
Mortality and Autopsy 04/16/2010 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 03/26/2003 Completed
P010015 MEDTRONIC Inc. MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM Cardiovascular 08/28/2001 Registry 08/28/2001 Completed
P950024
S002
MEDTRONIC Inc. MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 Cardiovascular 09/16/1999 Bipolar Model 4968 09/16/1999 Completed
P960009
S007
MEDTRONIC Inc. MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM Neurology 01/14/2002 VA Study 01/14/2002 Completed
P980035
S013
MEDTRONIC Inc. MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE Cardiovascular 03/26/2003 RESPECT 10/03/2003 Completed
P860004
S056
MEDTRONIC Inc. SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM General Hospital 09/12/2003 Synchromed II 09/12/2003 Completed
P060025 MEDTRONIC Inc. ATS 3F AORTIC BIOPROSTHESIS Cardiovascular 10/30/2008 ATS 3f 10/30/2008 Other
P060033 MEDTRONIC Inc. ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 02/01/2008 Registry PROTECT CA 02/01/2008 Completed
Product Testing 02/01/2008 Completed
Dual Antiplatelet Therapy EDUCATE 02/01/2008 Completed
5yr Clinical Outcomes 02/01/2008 Completed
P060039 MEDTRONIC Inc. ATTAIN STARFIX MODEL 4195 LEAD Cardiovascular 06/13/2008 Chronic Extraction 06/13/2008 Completed
Chronic Performance Study 06/13/2008 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 05/13/2008 Completed
P080006 MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD Cardiovascular 04/07/2009 Elution 04/07/2009 Completed
Chronic Lead Performance 04/07/2009 Completed
P080006
S002
MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD Cardiovascular 04/01/2011 Chronic Lead Performance 04/01/2011 Completed
P920015
S055
MEDTRONIC Inc. MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M Cardiovascular 01/09/2012 Chronic Lead Performance 01/09/2012 Completed
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 PAS of TS Feat w/sensor-aug w/comm data 10/11/2017 Completed
P980035
S277
MEDTRONIC Inc. ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR Cardiovascular 01/15/2013 SureScan Pacing System 12/19/2012 Completed
P140010 MEDTRONIC Inc. IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 12/30/2014 IN.PACT SFA Extended f/u study 06/19/2015 Completed
Cont f/u of Sub in SFA Global Clin Prog 06/19/2015 Completed
P140017 MEDTRONIC Inc. MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) Cardiovascular 01/27/2015 Long Term PAS 01/27/2015 Completed
New Enrollment Study 01/27/2015 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
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
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 12/27/2006 Completed
P970004
S022
MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology
09/24/2002 Single Tined Lead (protocol 1634) 09/24/2002 Completed
P080025 MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM Gastroenterology/
Urology
03/14/2011 FI-PAS 03/14/2011 Completed
P090029 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 07/24/2014 Extended Follow-Up 07/24/2014 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
P040001 MEDTRONIC SOFAMOR DANEK, INC. X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM Orthopedic 11/21/2005 LTOS Study 12/08/2006 Completed
COAST Study 11/21/2005 Terminated
P060018 MEDTRONIC SOFAMOR DANEK, INC. PRESTIGE CERVICAL DISC SYSTEM Orthopedic 07/16/2007 Enhanced Surveillance 07/16/2007 Completed
Long-Term Study 07/16/2007 Completed
P990020 Medtronic Vascular ANEURX STENT GRAFT SYSTEM Cardiovascular 09/28/1999 Long term 09/28/1999 Completed
P070007 Medtronic Vascular TALENT THORACIC STENT GRAFT SYSTEM Cardiovascular 06/05/2008 THRIVE Trial 06/05/2008 Terminated
P070012 Medtronic Vascular EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM Cardiovascular 10/23/2007 EMERGE 10/23/2007 Terminated
MAVErIC II Long Term Study 10/23/2007 Completed
P070027 Medtronic Vascular THE TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 04/15/2008 Vitality Trial 04/15/2008 Completed
P070027
S011
Medtronic Vascular TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 02/04/2010 Registry 02/04/2010 Terminated
P100021 Medtronic Vascular MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM Cardiovascular 12/16/2010 ENGAGE 05/09/2011 Completed
P100040 Medtronic Vascular VALIANT THORACIC STENT GRAFT SYSTEM Cardiovascular 04/01/2011 Captivia Delivery System 04/01/2011 Completed
P110013 Medtronic Vascular RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/17/2012 Resolute Integrity 02/17/2012 Completed
Cont Followup of Premarket and OUS Cohort 02/17/2012 Completed
P110040 Medtronic Vascular MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM Cardiovascular 09/19/2013 Complete SE SFA Long Term Study 09/19/2013 Completed
P110013
S005
Medtronic Vascular RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/22/2013 Resolute Integrity PAS Newly Enrolled 02/22/2013 Completed
Continued F/u of Premarket and OUS Cohort 02/22/2013 Completed
P100040
S012
Medtronic Vascular VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 Valiant Dissection PAS 01/22/2014 Terminated
P160043 MEDTRONIC VASCULAR RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 04/28/2017 Cont f/u RESOLUTE ONYX Clinical 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
P060001 MEDTRONIC VASCULAR INC PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS Cardiovascular 01/24/2007 CREATE (IDE) 08/02/2007 Completed
CREATE PAS 08/02/2007 Completed
P110023 MEDTRONIC VASCULAR INC EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Cardiovascular 03/07/2012 Durability PAS 03/07/2012 Completed
Cont FU of Premarket Cohort-Durability II PAS 03/07/2012 Completed
H080002 Medtronic, Inc MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM Cardiovascular 01/25/2010 Long Term PAS 01/25/2010 Terminated
Generalizability Study 04/06/2010 Terminated
P090013 Medtronic, Inc REVO MRI SURESCAN IPG AND PACING SYSTEM Cardiovascular 02/08/2011 Chronic Lead Performance/Multiple MRI 02/08/2011 Completed
P090013
S202
Medtronic, Inc CAPSUREFIX MRI SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems 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 05/13/2008 Completed
P890003
S179
Medtronic, Inc. CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE Cardiovascular 01/09/2012 Chronic Lead Performance 01/09/2012 Completed
P930039
S140
Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Completed
P930039
S151
Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 Cardiovascular 10/12/2016 MR conditional Tachy Therapys Systems 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 07/12/2002 Terminated
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 Device Failure Study 11/17/2006 Other
Informed Decision Process 11/17/2006 Completed
Adjunct Study 11/17/2006 Completed
Core 11/17/2006 Completed
Focus Group 11/17/2006 Completed
Breast Implant Case Control Studies 04/18/2014 Terminated
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery
06/14/2013 Post-Approval PMA Cohort Study (PACS) 06/14/2013 Completed
Post-approval Cont Access Study (PACAS) 06/14/2013 Completed
Breast Implant Case-Control Studies 06/14/2013 Terminated
Focus Group Study 06/14/2013 Completed
P040047 MERZ NORTH AMERICA, INC COAPTITE Gastroenterology/
Urology
11/10/2005 Coaptite 11/10/2005 Completed
P050037 MERZ NORTH AMERICA, INC RADIESSE 1.3CC AND 0.3CC General &
Plastic Surgery
12/22/2006 Radiesse 12/22/2006 Completed
P050052 MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
12/22/2006 Long Term (Nasolabial Folds) 12/22/2006 Completed
Short Term (Fitzpatrick) 12/22/2006 Completed
P090016 MERZ NORTH AMERICA, INC BELOTERO BALANCE General &
Plastic Surgery
11/14/2011 Chemical/Physical Evaluation 11/14/2011 Completed
Belotero Balance PAS 05/01/2012 Completed
Concentration and Molecular Weight 11/14/2011 Completed
P050052
S049
MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
06/04/2015 Radiesse Radiological Evaluation Study 09/02/2015 Completed
P100018 Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE Neurology 04/06/2011 Continued Follow-up of Premarket Cohort 04/06/2011 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 04/28/2006 Completed
P060027 MicroPort CRM USA Inc. OVATIO CRT SYSTEM Cardiovascular 05/15/2008 Long Term 10/31/2008 Other
P030027 MicroPort Orthopedics Inc. CERAMIC TRANSCEND HIP ARTICULATION Orthopedic 07/07/2003 Ceramic Transcend Hip 01/07/2003 Completed
P030042 MicroPort Orthopedics Inc. CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM Orthopedic 11/03/2009 ConservePlus Longer-Term PAS 11/03/2009 Terminated
ConservePlus New Enrollment PAS 11/03/2009 Terminated
P020031 MICROSULIS MEDICAL LTD. MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM Obstetrics/
Gynecology
09/23/2003 MEA PAS 09/23/2003 Completed
P140013 MINERVA SURGICAL MINERVA ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
07/27/2015 Minerva Pivotal Study 07/25/2015 Completed
Minerva Single-Arm Study 07/27/2015 Completed
P040025 Natus Medical Incorporated OLYMPIC COOL-CAP Neurology 12/20/2006 VON Registry 12/20/2006 Completed
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 Continued F/u -Long Term Treatment (LTT) 11/14/2013 Completed
Lead Extraction Study 11/14/2013 Completed
H100002 NEUROVASX CPAX ANEURYSM TREATMENT SYSTEM Neurology 04/01/2011 New Enrollment Study 09/12/2012 Other
P000023 NEXUS CMF, LLC TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES Dental 01/05/2001 TMJ Fossa-Eminence PAS 01/05/2001 Completed
P000035 NEXUS CMF, LLC TMJ FOSSA-EMINENCE PROSTHESIS(TM) Dental 02/27/2001 TMJ 02/27/2001 Completed
P000049 NMT MEDICAL, INC. CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD Cardiovascular 12/05/2001 Prospective VSD Registry 04/19/2002 Other
P000049
S016
NMT MEDICAL, INC. STARFLEX SEPTAL OCCLUSION SYSTEM Cardiovascular 03/05/2009 Fatigue & Corrosion Testing 03/05/2009 Other
P100012 NUVASIVE, INC. NUVASIVE PCM CERVICAL DISC SYSTEM Orthopedic 10/26/2012 PCM Cervical Long Term 10/26/2012 Completed
P070009 OBTECH MEDICAL GMBH REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X Gastroenterology/
Urology
09/28/2007 Realize PAS 09/28/2007 Completed
P130004 OCULAR THERAPEUTIX, INC. RESURE SEALANT Ophthalmic 01/08/2014 Clinical PAS 01/08/2014 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 ECD Study 09/10/2004 Completed
Long Term 09/10/2004 Completed
P000029 Palette Life Sciences DEFLUX INJECTABLE GEL Gastroenterology/
Urology
09/24/2001 Deflux Long-Term 09/24/2001 Completed
P050031 PARAGON VISION SCIENCES PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY Ophthalmic 11/16/2006 Paragon PAS 06/06/2007 Completed
P070005 PATHFINDER CELL THERAPY INC. REPEL-CV BIORESORBABLE ADHESION BARRIER Cardiovascular 03/06/2009 REPEL CV 03/06/2009 Other
P150039 Poseidon Medical Inc. TRYTON SIDE BRANCH STENT Cardiovascular 02/21/2017 TRYTON Side Branch Stent EA Confirmatory 02/21/2017 Completed
TRYTON Side Branch Stent PIVOTAL RCT 02/21/2017 Completed
P030050 Q-Med AB SCULPTRA AND SCULPTRA AESTHETIC General &
Plastic Surgery
08/03/2004 Long Term Registry 08/17/2009 Completed
P040024 Q-Med AB RESTYLANE INJECTABLE GEL General &
Plastic Surgery
03/25/2005 Restylane 03/25/2005 Completed
P030050
S002
Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 Pre Clinical PAS 09/09/2010 Completed
H030003 RELIANTHEART INC. DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM Cardiovascular 02/25/2004 HeartAssist 5 Pediatric VAD 02/25/2004 Terminated
P000008 ReShape Lifesciences, Inc. LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology
06/05/2001 HERO-002 06/05/2001 Completed
P000008
S017
ReShape Lifesciences, Inc. LAP-BAND Gastroenterology/
Urology
02/16/2011 LBMI-002 02/16/2011 Completed
Apollo-001 02/16/2011 Terminated
P130019 ReShape Lifesciences, Inc. MAESTRO RECHARGEABLE SYSTEM Gastroenterology/
Urology
01/14/2015 New Enrollment Study 07/24/2015 Other
P100020 Roche Molecular Systems, Inc. COBAS HPV TEST Microbiology 04/19/2011 MWP-HPV-159 04/19/2011 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 07/03/2018 Completed
P110008 RTI Surgical, Inc COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 Coflex Long-Term PAS 10/17/2012 Completed
P150034 RVO 2.0, Inc. (d.b.a. Optics Medical) Raindrop Near Vision Inlay Ophthalmic 06/29/2016 Raindrop Near Vision Inlay New Enrollment 01/24/2018 Other
P080009 Scott Laboratories, Inc SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM Anesthesiology 05/03/2013 Open Label PAS of SEDASYS Syst User Resp 03/29/2013 Terminated
Open Label Post Market Registry in Clinical Practi 03/29/2013 Terminated
P010039 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS SONOCUR BASIC SYSTEM Orthopedic 07/19/2002 Sonocur 07/19/2002 Terminated
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery
03/09/2012 Post-Approval Cont Access Study (PACAS) 05/29/2012 Completed
Post-Approval Case-Control Studies(PACCS) 03/09/2012 Terminated
Focus Group Study 06/07/2012 Completed
P140026 SILK ROAD MEDICAL, INC ENROUTE TRANSCAROTID STENT SYSTEM Cardiovascular 05/18/2015 ROADSTER 2 Registry 08/03/2015 Completed
P030022 Smith & Nephew, Inc. REFLECTION CERAMIC ACETABULAR SYSTEM Orthopedic 12/17/2004 Reflection Long Term 12/17/2004 Completed
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 UK Study 05/09/2006 Completed
P040028 SPECTRA SCIENCE LUMA CERVICAL IMAGING SYSTEM Obstetrics/
Gynecology
03/16/2006 LUMA 03/16/2006 Terminated
H060002 SPIRATION, INC. IBV VALVE SYSTEM Anesthesiology 10/24/2008 IBV Valve 10/24/2008 Completed
P030054 St. Jude Medical ST JUDE MEDICAL EPIC HF SYSTEM Cardiovascular 06/30/2004 Long Term 06/30/2004 Completed
P910023
S088
St. Jude Medical EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 03/14/2006 EPIC Notifiers 03/14/2006 Completed
P030054
S019
St. Jude Medical EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE Cardiovascular 03/14/2006 Longterm 03/14/2006 Completed
P910023
S154
St. Jude Medical PROMOTE CRT-D SYSTEM Cardiovascular 01/13/2009 SJ4 PAS 01/13/2009 Completed
P030054
S067
St. Jude Medical ATLAS II + HF CRT-D SYSTEM Cardiovascular 01/13/2009 SJ4 Post Approval Study 01/13/2009 Completed
P030054
S130
St. Jude Medical QUICKFLEX U MODEL 1258T LEAD Cardiovascular 05/10/2010 QuickFlex u Model 1258T LV lead 05/10/2010 Completed
P030054
S173
St. Jude Medical CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Cardiovascular 11/29/2011 QUAD PAS 11/29/2011 Completed
P970030 St. Jude Medical, Inc. TORONTO SPV VALVE Cardiovascular 11/04/1997 PAS 11/04/1997 Completed
P030035 St. Jude Medical, Inc. ANTHEM AND FRONTIER II CRT-P'S Cardiovascular 05/13/2004 Long term 05/13/2004 Completed
P040021 St. Jude Medical, Inc. SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE Cardiovascular 08/05/2005 Biocor & Biocor Supra Valves 08/03/2006 Completed
P950022
S042
St. Jude Medical, Inc. RIATA ST OPTIM AND RIATA STS OPTIM Cardiovascular 01/13/2009 SJ4 PAS 01/13/2009 Completed
P100029 St. Jude Medical, Inc. ST JUDE MEDICAL TRIFECTA VALVE Cardiovascular 04/20/2011 Trifecta Valve PAS 04/20/2011 Completed
P030016 STAAR Surgical Company VISIAN ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 12/22/2005 Axial Lengths 12/22/2005 Completed
Follow-up Study 12/22/2005 Completed
Adverse Event Study 12/22/2005 Completed
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 Stelkast Surpass Active PAS 05/12/2006 Terminated
P090012 STRATA SKIN SCIENCES, INC. MELAFIND General &
Plastic Surgery
11/01/2011 PAS of MelaFind 11/01/2011 Terminated
P020012 SUNEVA MEDICAL, INC. ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER General &
Plastic Surgery
10/27/2006 Study P521-01 10/27/2006 Completed
H100006 SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM (DPS) Anesthesiology 09/28/2011 NeuRx DPS 09/28/2011 Completed
P030011 SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) Cardiovascular 10/15/2004 Long Term 10/15/2004 Completed
P030011
S011
SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 INTERMACS Companion 05/16/2012 Completed
P140002 TERUMO MEDICAL CORPORATION MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM Cardiovascular 05/22/2015 OSPREY Extended f/u study 05/22/2015 Completed
P920014
S016
THORATEC CORP. THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) Cardiovascular 11/06/2002 Continued Access/Registry/IDE 11/06/2002 Completed
P060040 THORATEC CORP. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 04/21/2008 INTERMACS Registry 04/21/2008 Completed
H070004 THORATEC CORP. CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) Cardiovascular 10/07/2008 Centrimag PAS 10/07/2008 Completed
P060040
S005
THORATEC CORP. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 01/20/2010 Destination Therapy-INTERMACS 05/07/2010 Completed
Heartmate II Bleeding Study 05/07/2010 Completed
P870072
S027
THORATEC LABORATORIES CORP. THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) Cardiovascular 08/03/2004 Thoratec IVAD 08/03/2004 Completed
P980052 TMJ CONCEPTS TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS Dental 07/02/1999 Long term 07/02/1999 Completed
P100049 TORAX MEDICAL LINX REFLUX MANAGEMENT SYSTEM Gastroenterology/
Urology
03/22/2012 Extended f/u of premarket cohort 03/22/2012 Completed
H130006 TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM Gastroenterology/
Urology
12/18/2015 HDE Post-Approval Study Completed
P040050 UROPLASTY, LLC MACROPLASTIQUE IMPLANTS Gastroenterology/
Urology
10/30/2006 Enhanced Surveillance 10/30/2006 Completed
P050034 VISIONCARE, INC. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 Premarket Cohort IMT-002-LTME 10/13/2010 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 Training Study 08/31/2005 Completed
Cohort Study 03/23/2005 Completed
P040043
S051
W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 TAG Post-Approval Study 09/10/2013 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
P020004 W.L. GORE & ASSOCIATES,INC EXCLUDER BIFURCATED ENDOPROSTHESIS Cardiovascular 11/06/2002 PAS 11/06/2002 Completed
P020004
S006
W.L. GORE & ASSOCIATES,INC EXCLUDER BIFURCATED ENDOPROTHESIS Cardiovascular 06/02/2004 Long Term Follow up 06/02/2004 Completed
P050006 W.L. GORE & ASSOCIATES,INC GORE HELEX SEPTAL OCCLUDER Cardiovascular 08/11/2006 GORE HELEX 08/11/2006 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 10/18/2013 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 09/19/2014 Completed
P110002 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Extended f/u of premarket cohort 05/27/2014 Completed
P110009 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Long Term PAS 08/23/2013 Completed
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Trilogy PAS 06/04/2010 Terminated
P010030
S056
ZOLL MANUFACTURING CORPORATION LIFEVEST WEARABLE DEFIBRILLATOR Cardiovascular 12/17/2015 PMA Post-Approval Study 12/17/2015 Completed


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