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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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P980040
S039
ABBOTT MEDICAL OPTICS INC TECNIS TORIC 1-PEICE INTRAOCULAR LENS Ophthalmic 04/15/2013 OSB Lead-New Enrollment of Post Approval Study 08/25/2015 Progress Adequate
P980040
S058
ABBOTT MEDICAL OPTICS INC TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU Ophthalmic 07/31/2015 OSB Lead-ECR IOL PAS Progress Adequate
P980040
S065
ABBOTT MEDICAL OPTICS INC TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS Ophthalmic 07/15/2016 OSB Lead-TECNIS Symfony Toric New Enrollment Study Protocol Pending
P110019
S066
ABBOTT VASCULAR XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 OSB Lead-Extended Followup of the EXPERT CTO Study 10/03/2014 Progress Adequate
P040012
S034
ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM Cardiovascular 05/06/2011 OSB Lead-CANOPY Trial 03/04/2016 Progress Adequate
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 OSB Lead-Comprehensive/Linked-Registry Based Surv 06/13/2014 Progress Adequate
OSB Lead-New EnrollMitraClip Analysis Cohort (MAC) 04/05/2016 Progress Adequate
P070015
S122
ABBOTT VASCULAR INC. XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 OSB Lead-Extended followup of the EXPERT CTO Study 10/03/2014 Progress Adequate
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ODE Lead ABSORB IV Post-Approval Study Study Pending
OSB Lead-ABSORB USA Post Approval Clinical Study Protocol Pending
P140003
S004
ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEMS Cardiovascular 04/07/2016 OSB Lead-Impella AMI CS PAS 08/09/2016 Progress Adequate
P140003
S005
ABIOMED, INC. IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM Cardiovascular 04/07/2016 OSB Lead-Impella PCCS PAS 08/09/2016 Progress Adequate
P140003 ABIOMED, INC. IMPELLA Cardiovascular 03/23/2015 OSB Lead-New Enrollment Study Progress Adequate
H140001 ABIOMED, INC. IMPELLA RP SYSTEM Cardiovascular 01/23/2015 OSB Lead-Impella RP Pediatric Study 01/23/2015 Progress Adequate
OSB Lead-Impella RP Prospective Study 01/23/2015 Progress Adequate
P120023 ACUFOCUS, INC. KAMRA INLAY Ophthalmic 04/17/2015 OSB Lead-New Enrollment Study 05/12/2016 Study Pending
ODE Lead PAS-Continuation Study Progress Adequate
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 ODE Lead-Post-Approval Clinical Study Progress Adequate
OSB Lead-Enhanced Safety Surveillance Study 12/17/2015 Progress Adequate
P020024
S037
AGA MEDICAL CORP. AMPLATZER DUCT OCCLUDER II Cardiovascular 08/18/2013 OSB Lead-Continued F/u of the Premarket ADO II PAS 11/08/2013 Progress Adequate
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 ODE Lead-COMPASS Extenstion Study Study Pending
OSB Lead-Cypass Micro Stent New Enrollment PAS Protocol Pending
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 OSB Lead-Re-Op Phase 01/16/2015 Progress Adequate
OSB Lead-BIFS (Large PAS) 08/03/2015 Progress Inadequate
OSB Lead-Natrelle and 410 Combined Cohort 08/25/2016 Progress Adequate
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 OSB Lead-Natrelle and 410 Combined Cohort 08/25/2016 Progress Adequate
P000008 APOLLO ENDOSURGERY INC LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology
06/05/2001 OSB Lead-HERO-002 03/28/2016 Progress Inadequate
OSB Lead-Lap-Band Long Term 06/05/2001 Revised/Replaced Study
P000008
S017
APOLLO ENDOSURGERY INC LAP-BAND Gastroenterology/
Urology
02/16/2011 OSB Lead-Apollo-001 03/03/2016 Progress Inadequate
P140008 APOLLO ENDOSURGERY INC ORBERA INTRAGASTRIC BALLOON Gastroenterology/
Urology
08/05/2015 OSB Lead-ORBERA PAS (OPAS-001) 02/26/2016 Progress Adequate
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology
06/14/2016 ODE Lead-PATHWAY Clinical Trial PAS Study Pending
OSB Lead-AspireAssist Post-Approval Study Study Pending
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 OSB Lead-AtriCure Synergy Ablation System 06/13/2014 Progress Adequate
P070014
S022
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 OSB Lead-LifeStent SOLO 07/11/2014 Progress Adequate
P070014
S037
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 Popliteal Indication Post-Approval Surv Project Study Pending
P070014
S010
BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 OSB Lead-CONTINUUM Long Lesion 07/11/2014 Progress Adequate
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 OSB Lead-CONTINUUM 07/11/2014 Progress Adequate
P030002
S027
Bausch & Lomb, Inc. TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 OSB Lead-New Enrollment Study 02/09/2016 Progress Adequate
P020014
S017
BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
02/24/2012 OSB Lead-Essure/post-NovaSure PAS 09/29/2016 Progress Adequate
P020014
S041
BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/29/2015 ODE Lead-Post Approval Study 04/28/2016 Study Pending
H100004 Berlin Heart Inc. EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE Cardiovascular 12/16/2011 OSB Lead-All Comers Registry 07/27/2012 Progress Adequate
P000018 BEST VASCULAR, INC BETA-CATH (TM) SYSTEM Cardiovascular 11/03/2000 OSB Lead-Beta-Cath Long Term 02/23/2011 Progress Inadequate
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 OSB Lead-Long Term PAS 01/04/2013 Progress Adequate
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 ODE Lead-Extended f/u of Premarket Cohort 03/18/2016 Progress Adequate
P030031
S011
BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 OSB Lead-Atrial Fibrillation Registry 09/23/2011 Progress Adequate
OSB Lead-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 OSB Lead-CELESTIAL Study 12/23/2010 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 OSB Lead-Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P980023
S057
BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 OSB Lead-Protego DF4 Post Approval Registry 07/03/2014 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 OSB Lead-ProMRI ICD Post-Approval Study Study Pending
P050023
S094
BIOTRONIK, INC. IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) Cardiovascular 05/02/2016 OSB Lead-ProMRI ICD/CRT-D System Home Monitorin Study Pending
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 OSB Lead-Relay Thoracic Stent-Graft w Plus Del Sys 03/06/2015 Progress Adequate
P910073
S077
BOSTON SCIENTIFIC ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 01/14/2011 Progress Adequate
P960040
S198
BOSTON SCIENTIFIC TELIGEN 4-SITE MODELS Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 12/21/2012 Progress Adequate
P010012
S212
Boston Scientific Corp. COGNIS 4-SITE MODELS Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 01/14/2011 Progress Adequate
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 OSB Lead-New Patient Study 09/14/2010 Progress Adequate
P010012
S230
Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 OSB Lead-MADIT-CRT ACC NCDR 01/18/2013 Progress Inadequate
P010012
S160
Boston Scientific Corp. ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 Cardiovascular 05/16/2008 OSB Lead - ACUITY Long-Term Registry 06/25/2009 Progress Inadequate
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 OSB Lead-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 OSB Lead-PROMUS Element Plus US PAS 08/24/2012 Progress Adequate
P110010 Boston Scientific Corp. PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 11/22/2011 OSB Lead-PROMUS Element Plus US PAS 05/10/2012 Progress Adequate
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 ODE Lead-Continued f/u of IDE Cohorts Progress Adequate
OSB Lead-WATCHMAN New Enrollment (NESTed-PAS) 11/30/2016 Revised/Replaced Study
OSB Lead-WATCHMAN Comprehensive/Linked-Registry 11/30/2016 Progress Adequate
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 ODE Lead-ACUITY X4 Post Approval Study Progress Adequate
P150003 BOSTON SCIENTIFIC CORPORATION SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 10/02/2015 ODE Lead-EVOLVE Short DAPT Stu;dy Study Pending
P140028 BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM Cardiovascular 07/21/2015 ODE Lead-SuperNOVA Continued f/u study Progress Adequate
P110042 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 OSB Lead-S-ICD PAS Registry 09/28/2012 Progress Inadequate
P150012 BOSTONSCIENTIFIC IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD Cardiovascular 04/25/2016 ODE Lead-INGEVITY and SAMURAI Progress Adequate
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 OSB Lead-PAS of HeartLight Endoscopic Ablation Sys Progress Adequate
P150017 Cartiva, Inc CARTIVA SYNTHETIC CARTILAGE IMPLANT Orthopedic 07/01/2016 ODE Lead MOTION Extend Study Study Pending
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 ODE Lead-Post-Approval Study Progress Adequate
P130016 Cochlear Americas NUCLEUS HYBRID L24 IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 OSB Lead-Extended f/u study 09/11/2014 Progress Adequate
OSB Lead-New Enrollment Study 04/08/2015 Progress Inadequate
P890055
S026
CODMAN CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 OSB Lead-Leachables Study 03/15/2011 Progress Adequate
OSB Lead-Drug Stability Study 03/15/2011 Progress Adequate
P100022 COOK MEDICAL INCORPORATED ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 OSB Lead-Zilver PTX Stent PAS 01/13/2015 Progress Inadequate
OSB Lead-New US Enrollment 02/15/2013 Progress Adequate
P140016 COOK MEDICAL INCORPORATED ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT Cardiovascular 09/15/2015 ODE Lead-Post-Approval Study Progress Adequate
P020018
S040
COOK, INC. ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 OSB Lead-Long Term F/U Study 12/12/2012 Progress Adequate
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 OSB Lead-Long Term Study 11/04/2008 Progress Adequate
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 OSB Lead-Duraloc Long Term 05/03/2005 Revised/Replaced Study
P070026 DEPUY ORTHOPAEDICS, INC. CERAMAX CERAMIC HIP SYSTEM Orthopedic 12/23/2010 OSB Lead-Ceramax PAS 03/18/2015 Progress Inadequate
P070026
S004
DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 OSB Lead-Long-Term F/U of IDE COC36 patients 03/10/2015 Progress Adequate
OSB Lead-Short-Mid-Term F/u of New COC36 patients 03/12/2015 Progress Adequate
OSB Lead-COC36 PAS: UK & Australian Natl Joint Reg 11/21/2013 Progress Adequate
P110014 DUNE MEDICAL DEVICES INC DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery
12/27/2012 OSB Lead-MarginProbe System US PAS 04/29/2014 Progress Inadequate
P110021 EDWARDS LIFESCIENCES LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/19/2012 OSB Lead-Newly Enrolled Study 09/13/2013 Progress Adequate
P100041 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 11/02/2011 OSB Lead-Newly Enrolled Study 08/28/2014 Progress Adequate
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 OSB Lead-Cont F/U of the IDE inop pts cohort(B) 08/02/2016 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Based Surv 06/16/2014 Progress Adequate
P860057
S029
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 OSB Lead-Long Term 01/24/2014 Progress Adequate
P860057
S042
EDWARDS LIFESCIENCES, LLC. CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 05/07/2009 OSB Lead-Clinical Study 11/03/2009 Progress Adequate
P130009
S034
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 ODE Lead-Continued f/u of the premarket cohort 08/19/2016 Progress Adequate
OSB Lead-Comprehensive Linked Registry-Based Surv Progress Adequate
P130009
S037
EDWARDS LIFESCIENCES, LLC. SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 02/29/2016 ODE Lead-COMPASSION Cohort Progress Adequate
OSB Lead-New Enrollment SAPIEN XT Pulmonic PAS 09/20/2016 Study Pending
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 ODE Lead-Continued f/u of premarket cohort 08/19/2016 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Study Pending
P140031
S010
EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 ODE Lead-Continued f/u of premarket cohort Study Pending
OSB Lead-Novel Surveillance Study Pending
P130009
S057
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 ODE Lead-Continued f/u of premarket cohort Study Pending
OSB Lead-Novel Surveillance Study Pending
P130019 ENTEROMEDICS INC. MAESTRO RECHARGEABLE SYSTEM Gastroenterology/
Urology
01/14/2015 ODE Lead-Extended F/u of Premarket Cohort 06/27/2016 Progress Adequate
OSB Lead-New Enrollment Study Progress Inadequate
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 OSB Lead-New Enrollment 03/18/2016 Revised/Replaced Study
OSB Lead-Esteem New Enrollment 2 03/18/2016 Progress Adequate
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 OSB Lead-Epi proColon PAS Study Pending
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 OSB Lead-Cologuard PAS 09/25/2015 Progress Adequate
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 OSB Lead-Novation PAS 12/09/2010 Progress Adequate
OSB Lead-Long Term 12/09/2010 Revised/Replaced Study
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 OSB Lead-Prometra Programmable Pump system 12/28/2015 Progress Adequate
OSB Lead-Extended Use Stability Study 05/04/2012 Progress Adequate
OSB Lead-Leachables Study 05/04/2012 Progress Adequate
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 OSB Lead-New Enrollment Study 05/13/2016 Progress Adequate
OSB Lead-Registry Study 07/21/2015 Revised/Replaced Study
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 OSB Lead-Extended f/u of premarket cohort 07/16/2014 Progress Adequate
OSB Lead-Enhanced Surveillance 05/08/2014 Progress Adequate
P950039
S026
HOLOGIC, INC. THINPREP-5000 Pathology 03/02/2015 OIR Lead-Post-Approval Study Progress Adequate
P010013
S041
HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
02/01/2013 OSB Lead-NovaSure PAS 06/15/2015 Progress Adequate
P120011 IDEALIMPLANT IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT General &
Plastic Surgery
11/14/2014 OSB Lead-Post-Approval PMA Cohort Study (PACS) 11/14/2014 Progress Adequate
P110039 InSightec EXABLATE General &
Plastic Surgery
10/18/2012 OSB Lead-New Enrollment Study 03/15/2013 Progress Adequate
OSB Lead-Enhanced Surveillance Registry Study 03/15/2013 Progress Adequate
P150038 InSightec EXABLATE Neurology 07/11/2016 ODE Lead-Long Term PAS Study Pending
P040003
S015
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
08/31/2015 OSB Lead-Post ExAblate Pregnancy Outcomes Registry Progress Adequate
P040003
S016
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
10/05/2015 ODE Lead-Study to Evaluate Safety of ExAblate Progress Adequate
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 OSB Lead-Ext FU Premkt Cohort Inspire 4 STAR Trial 04/30/2014 Progress Adequate
OSB Lead-New Enrollment Study 06/01/2016 Progress Inadequate
P080013 INTEGRA LIFESCIENCES CORPORATION DURASEAL EXACT SPINE SEALANT SYSTEM Neurology 09/04/2009 OSB Lead-DuraSeal Exact Spine Sealant System 02/03/2016 Progress Adequate
P000057 INTEGRA LIFESCIENCES CORPORATION ASCENSION MCP Orthopedic 11/19/2001 OSB Lead-Ascension MCPT 02/08/2002 Progress Inadequate
H130001 KANEKA PHARMA AMERICA LLC KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN Gastroenterology/
Urology
03/05/2015 OSB Lead-New Enrollment Study 08/24/2015 Progress Inadequate
H120005 KANEKA PHARMA AMERICA LLC LIPOSORBER LA-15 SYSTEM Gastroenterology/
Urology
10/10/2013 OSB Lead-New Enroll. PAS for Liposorber LA-15 Sys 02/19/2016 Progress Inadequate
P110002 LDR Spine USA MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 OSB Lead-Extended f/u of premarket cohort 05/27/2014 Progress Adequate
OSB Lead-Enhanced Surveillance System 06/03/2014 Progress Adequate
OSB Lead-Retrieval Analysis 07/15/2014 Progress Adequate
P110009 LDR SPINE USA INC. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 OSB Lead-Long Term PAS 05/08/2014 Progress Adequate
OSB Lead-Enhanced Surveillance System 05/19/2014 Progress Adequate
OSB Lead-Retrieval Analysis 07/15/2014 Progress Adequate
P060038
S017
LivaNova Canada Corp. MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL Cardiovascular 04/18/2014 OSB Lead-NEMO PAS 11/25/2014 Progress Adequate
P110032 LOMBARD MEDICAL TECHNOLOGIES INC AORFIX FLEXIBLE STENT GRAFT SYSTEM Cardiovascular 02/14/2013 OSB Lead-Comprehensive/Linked-Registry Based Surv Progress Adequate
P130024 LUTONIX LUTONIX DRUG COATED BALLOON PTA CATETER Cardiovascular 10/09/2014 OSB Lead-PAS 1 (Extended Follow-up Study) 10/09/2014 Progress Adequate
OSB Lead-PAS 2 (New Enroll. of Female Pat. Study) 10/14/2016 Progress Adequate
P000025
S084
MED-EL CORP. MED-EL COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 09/15/2016 ODE Lead-MED-EL EAS Extended f/u Study Protocol Pending
P030006 MEDIFOCUS, INC PROLIEVE THERMODILATATION SYSTEM Gastroenterology/
Urology
02/19/2004 OSB Lead-Prolieve PAS 03/11/2005 Progress Adequate
P110004
S001
MEDINOL LTD. NIRXCELL COCR CORONARY STENT ON RX SYSTEM Cardiovascular 12/19/2013 OSB Lead-NIRTRAKS 06/24/2016 Progress Adequate
P100047 Medtronic HEARTWARE VENTRICULAR ASSIST SYSTEM Cardiovascular 11/20/2012 OSB Lead-Newly Enrolled (HW-PAS-01) 01/15/2016 Progress Adequate
OSB Lead-Training Program (HeartWare-PAS-02) 09/25/2015 Progress Adequate
OSB Lead-Continued Follow-Up (HW-PAS-03) 02/14/2014 Progress Adequate
P010031
S232
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT Cardiovascular 04/04/2012 OSB Lead-REVERSE NCDR ICD Registry Study 06/29/2012 Progress Adequate
OSB Lead-REVERSE Product Surveillance Registry 09/17/2012 Progress Inadequate
P890003
S252
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER Cardiovascular 01/15/2013 OSB Lead-SureScan Pacing System 01/15/2014 Progress Adequate
P010031
S176
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P980016
S216
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P890003
S179
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P930039
S140
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CAPSUREFIX NOVUS MRI SURESCAN Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
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 OSB LeadMR conditional Tachy Therapy Systems Study Progress Adequate
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 OSB Lead-Post-Approval Study Study Pending
P890003
S329
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK MONITOR AND EXPRESS MONITOR, CARDIOSIGHT READER; CARELINK EXPRESS Cardiovascular 09/11/2015 OSB Lead-Evera MRI System PAS Study Pending
P980016
S536
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S Cardiovascular 09/11/2015 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P130021
S010
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 03/30/2015 ODE Lead-Continued f/u of the premarket cohort Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Progress Adequate
P130021
S016
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS Cardiovascular 11/10/2015 ODE Lead-Continued f/u of premarket cohort Study Pending
OSB Lead-Comprehensive/Linked-Registry Based Surv Study Pending
P130021 MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 ODE Lead-Contined f/u of IDE pivotal cohort 02/17/2014 Revised/Replaced Study
ODE Lead-Continued f/u of continued access cohort 02/17/2014 Revised/Replaced Study
P130021
S002
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 ODE Lead-Continued f/u of the premarket cohorts 06/12/2014 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Based Surv 06/12/2014 Progress Adequate
P100010 Medtronic CryoCath LP ARCTIC FRONT CRYOCATHETER SYSTEM Cardiovascular 12/17/2010 OSB Lead-STOP AF PAS 08/31/2016 Progress Adequate
P920015
S055
MEDTRONIC Inc. MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P080006
S004
MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD Cardiovascular 03/31/2011 OSB Lead-Attain Ability Straight Model 4396 06/29/2015 Progress Adequate
P080006
S002
MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD Cardiovascular 04/01/2011 OSB Lead-Chronic Lead Performance 04/01/2011 Progress Adequate
P060039 MEDTRONIC Inc. ATTAIN STARFIX MODEL 4195 LEAD Cardiovascular 06/13/2008 OSB Lead-Chronic Performance Study 11/19/2013 Progress Adequate
P080006 MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD Cardiovascular 04/07/2009 OSB Lead-Chronic Lead Performance 12/05/2013 Progress Inadequate
P980035
S277
MEDTRONIC Inc. ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR Cardiovascular 01/15/2013 OSB Lead-SureScan Pacing System 12/19/2012 Progress Adequate
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 OSB Lead-PAS of TS Feat. w Sensor-Augment Pump Sys 09/18/2015 Progress Inadequate
P980035
S442
MEDTRONIC Inc. ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE Cardiovascular 04/28/2016 OSB Lead-Post-Approval Study Study Pending
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 OSB Lead-Post-Approval Study Study Pending
P080006
S085
MEDTRONIC Inc. ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 ODE Lead-Micra Rate Resp Conf Study Study Pending
OSB Lead-Micra Transcatheter Pacing System PAS Progress Adequate
P140010
S015
MEDTRONIC Inc. IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 09/07/2016 OSB Lead-Surveillance Post Market Registry Protocol Pending
P080006
S068
MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD Cardiovascular 08/01/2014 OSB Lead-Post-Approval Study Registry 08/01/2014 Progress Adequate
P920015
S151
MEDTRONIC Inc. SPRINT QUATTRO SECURE S MRI SURESCAN AND SPRINT QUATTRO SECURE MRI SURESCAN Cardiovascular 09/11/2015 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P140010 MEDTRONIC Inc. IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 12/30/2014 OSB Lead-IN.PACT SFA Extended f/u study 06/19/2015 Progress Adequate
OSB Lead-Cont f/u of Sub in SFA Global Clin Prog 06/19/2015 Progress Adequate
P140017 MEDTRONIC Inc. MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) Cardiovascular 01/27/2015 OSB Lead-Long Term PAS 01/27/2015 Progress Adequate
OSB Lead-New Enrollment Study 01/27/2015 Progress Adequate
P080006
S073
MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS Cardiovascular 12/10/2014 OSB Lead-Post-Approval Study Registry 12/10/2014 Progress Adequate
P160017 MEDTRONIC MINIMED MiniMed 670G System Clinical Chemistry 09/28/2016 OIR Lead-Post Approval Study Protocol Pending
P970004
S022
MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology
09/24/2002 OSB Lead-Urgency Frequency (UF 1635) 10/23/2007 Revised/Replaced Study
OSB Lead-Urinary Urge Incontinence (UUI) 10/23/2007 Revised/Replaced Study
OSB Lead-Single Tined Lead (protocol 1634) 04/02/2010 Progress Adequate
P060023 Medtronic Sofamor Danek USA, Inc. BRYAN CERVICAL DISC PROSTHESIS Orthopedic 05/12/2009 OSB Lead-Long-Term Study 05/12/2009 Progress Adequate
OSB Lead-Enhanced Surveillance 05/12/2009 Progress Adequate
P090029 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 07/24/2014 OSB Lead-Extended Follow-Up 07/24/2014 Progress Inadequate
OSB Lead-Enhanced Surveillance Study 04/06/2015 Progress Adequate
OSB Lead-Device Failure 03/11/2016 Progress Adequate
P090029
S003
Medtronic Sofamor Danek USA, Inc. PRESTIGE LP(TM) CERVICAL DISC Orthopedic 07/07/2016 ODE Lead-10 Year Extended f/u of IDE Subjects Study Pending
OSB Lead-PRESTIGE LP 2-Level Metal Concentrations Study Pending
P100021 Medtronic Vascular MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM Cardiovascular 12/16/2010 OSB Lead-ENGAGE 01/24/2014 Progress Adequate
P110013
S005
Medtronic Vascular RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/22/2013 OSB Lead-Resolute Integrity PAS Newly Enrolled 10/16/2014 Progress Adequate
OSB Lead-Continued F/u of Premarket and OUS Cohort 02/22/2013 Progress Adequate
P100040
S012
Medtronic Vascular VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 OSB Lead-Comprehensive/Linked-Registry Based Surv. Progress Adequate
P110023 MEDTRONIC VASCULAR INC EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Cardiovascular 03/07/2012 OSB Lead-Durability II PAS 11/23/2016 Progress Adequate
P090013 Medtronic, Inc REVO MRI SURESCAN IPG AND PACING SYSTEM Cardiovascular 02/08/2011 OSB Lead-Chronic Lead Performance/Multiple MRI 02/08/2011 Progress Adequate
P090013
S202
Medtronic, Inc CAPSUREFIX MRI SURESCAN Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P090013
S205
Medtronic, Inc CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI Cardiovascular 04/28/2016 OSB Lead-Post-Aproval Study Study Pending
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 OSB Lead-Re-Op Phase 01/16/2015 Progress Adequate
OSB Lead-Large PAS 10/01/2014 Revised/Replaced Study
OSB Lead-MemoryGel and Shape Glow Study 02/12/2016 Progress Adequate
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery
06/14/2013 OSB Lead-MemoryGel and Shape Glow Study 02/12/2016 Progress Adequate
P040047 MERZ NORTH AMERICA, INC COAPTITE Gastroenterology/
Urology
11/10/2005 OSB Lead-Coaptite 09/29/2008 Progress Adequate
P050052
S049
MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
06/04/2015 OSB Lead-Radiesse Radiological Evaluation Study 01/20/2016 Progress Adequate
OSB Lead-Radiesse New Enrollment Study Progress Adequate
P100018 MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE Neurology 04/06/2011 OSB Lead-Continued Follow-up of Premarket Cohort 06/27/2011 Progress Inadequate
P140013 MINERVA SURGICAL MINERVA ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
07/27/2015 ODE Lead-Minerva Single-Arm Study Progress Adequate
ODE Lead-Minerva Pivotal Study 07/25/2015 Progress Adequate
P010047 NEOMEND, INC. PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 01/14/2010 OSB Lead-Long Term Safety 03/16/2015 Progress Adequate
P010047
S010
NEOMEND, INC. NEOMEND PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 12/21/2011 OSB Lead-NeoMend ProGel Pleural Air Leak Sealant 03/16/2015 Progress Adequate
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 OSB Lead-New Enrollment - All Comers 06/30/2015 Progress Inadequate
OSB Lead-New Enrollment -Performance & Programming 06/30/2015 Progress Adequate
OSB Lead-Lead Extraction Study 02/18/2014 Progress Adequate
OSB Lead-Autopsy Study 02/14/2014 Progress Adequate
OSB Lead-Continued F/u -Long Term Treatment (LTT) 09/05/2014 Progress Adequate
P100034 Novocure, Ltd. NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 OSB Lead-Registry Study for Optune System 02/09/2016 Progress Adequate
OSB Lead-New Enrollment Study for NovoTTF-100A 02/09/2016 Revised/Replaced Study
P150028 NUMED, INC. CHEATHAM PLATINUM STENT SYSTEM Cardiovascular 03/25/2016 ODE Lead-Continued f/u of Premarket Cohorts Study Pending
ODE Lead-Cont f/u of premarket cohorts w/stent fra Study Pending
P100012 NUVASIVE, INC. NUVASIVE PCM CERVICAL DISC SYSTEM Orthopedic 10/26/2012 OSB Lead-PCM Cervical Enhanced Surveillance 08/25/2015 Progress Adequate
OSB Lead-PCM Cervical Long Term 02/06/2013 Progress Adequate
P160001 OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM Gastroenterology/
Urology
09/08/2016 OSB Lead-Obalon Balloon System PAS Protocol Pending
P130004 OCULAR THERAPEUTICS, INC. RESURE SEALANT Ophthalmic 01/08/2014 OSB Lead-Device Exposure Registry Study 07/21/2016 Study Pending
P000037
S030
On-X Life Technologies, Inc. ON-X PROSTHETIC HEART VALVE Cardiovascular 04/01/2015 OSB Lead-Newly Enrolled On-X PAS 01/06/2016 Progress Adequate
P030028 OPHTEC BV ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) Ophthalmic 09/10/2004 OSB Lead-ECD Study 09/10/2004 Progress Adequate
OSB Lead-Long Term 11/10/2011 Progress Adequate
P110008 PARADIGM SPINE, LLC COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 OSB Lead-Coflex Long-Term PAS 04/23/2013 Progress Adequate
OSB Lead-Coflex Actual Practice PAS USA Progress Inadequate
OSB Lead-Coflex Actual Practice PAS 04/23/2013 Revised/Replaced Study
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 OSB Lead-Nit-Occlud PDA PAS 08/01/2014 Progress Inadequate
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology
11/18/2011 OSB Lead-Registry Study 11/13/2013 Progress Inadequate
OSB Lead-Deep Hyperthermia and Radiation 11/13/2013 Revised/Replaced Study
OSB Lead-Enhanced Surveillance Study 11/13/2013 Progress Inadequate
P030050
S002
Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 OSB Lead-Clinical PAS 04/23/2014 Progress Adequate
P140012 RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM Gastroenterology/
Urology
07/28/2015 OSB Lead-REDUCE PAS 01/14/2016 Progress Inadequate
P150034 REVISION OPTICS, INCORPORATED Raindrop Near Vision Inlay Ophthalmic 06/29/2016 ODE Lead Post-Approval Study Study Pending
OSB Lead-Raindrop Near Vision Inlay New Enrollment Protocol Pending
P100020
S017
Roche Molecular Systems, Inc. COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS Microbiology 07/07/2016 OIR Lead-COB-HPV-301 Post Approval Study Study Pending
H110002 SECOND SIGHT, LLC. ARGUS II RETINAL PROSTHESIS SYSTEM Ophthalmic 02/13/2013 OSB Lead-New Enrollment Argus II 09/18/2015 Progress Inadequate
OSB Lead-Ext f/u of the Argus II Feasibility Study 02/13/2013 Progress Adequate
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery
03/09/2012 OSB Lead-US Post-Approval Study (US-PAS) 05/29/2012 Progress Adequate
OSB Lead-Post-Approval PMA Cohorts Study (PACS) 05/29/2012 Progress Adequate
P140026 SILK ROAD MEDICAL, INC ENROUTE TRANSCAROTID STENT SYSTEM Cardiovascular 05/18/2015 OSB Lead-ROADSTER 2 Registry 07/19/2016 Progress Adequate
P150030 Smith & Nephew, Inc. R3 DELTA CERAMIC HIP SYSTEM Orthopedic 10/17/2016 ODE Lead-Long-Term F/u of EU patients PAS Study Pending
OSB Lead-Short to Mid-Term f/u of New US Patients Study Pending
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 OSB Lead-US Study 05/09/2006 Progress Adequate
P150004 Spinal Modulation, Inc Axium Neurostimulator System Neurology 02/11/2016 F/U of the Axium Neurostimulator System (FANS) 05/26/2016 Progress Adequate
P030054
S130
St. Jude Medical QUICKFLEX U MODEL 1258T LEAD Cardiovascular 05/10/2010 OSB Lead-QuickFlex u Model 1258T LV lead 05/10/2010 Progress Adequate
P030054
S173
St. Jude Medical CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Cardiovascular 11/29/2011 OSB Lead-QUAD PAS 03/02/2012 Progress Adequate
P100045 St. Jude Medical CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Cardiovascular 05/28/2014 OSB Lead-Newly Enrolled Champion 05/28/2014 Progress Adequate
OSB Lead-Champion Substudy 08/29/2014 Progress Adequate
P130026 St. Jude Medical TACTICATH QUARTZ SET Cardiovascular 10/24/2014 OSB Lead-TactiCath Quartz PAS 08/20/2014 Progress Adequate
P040040 St. Jude Medical Cardiovascular Division AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 OSB Lead-Post Approval Study 03/18/2016 Progress Adequate
P120021 St. Jude Medical, Inc. AMPLATZER PFO OCCLUDER Cardiovascular 10/28/2016 OSB Lead-Amplatzer PFO Occulder New Enrollment PAS Protocol Pending
P950022
S085
St. Jude Medical, Inc. OPTISURE Cardiovascular 02/21/2014 OSB Lead-OptiSure Lead Post Approval Study 02/21/2014 Progress Adequate
OSB Lead-Externalization and Abrasion Sub-Study 02/21/2014 Progress Adequate
P030016 STAAR SURGICAL CO. VISIAN ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 12/22/2005 OSB Lead-Adverse Event Study 06/08/2012 Progress Adequate
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 OSB Lead-Long term 05/12/2006 Revised/Replaced Study
P090012 STRATA SKIN SCIENCES, INC. MELAFIND General &
Plastic Surgery
11/01/2011 OSB Lead-PAS of MelaFind 10/22/2014 Progress Adequate
P050050 STRYKER CORPORATION SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 OSB Lead-Long Term Study 05/09/2014 Progress Adequate
OSB Lead-Actual Conditions of Use Study (STAR 2) 09/01/2016 Progress Inadequate
H100006 SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM (DPS) Anesthesiology 09/28/2011 OSB Lead-NeuRx DPS 09/28/2011 Progress Adequate
P030011
S011
SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 OSB Lead-INTERMACS Companion 11/27/2015 Progress Adequate
OSB Lead-Enhanced Surveillance 08/20/2012 Revised/Replaced Study
P070001 SYNTHES SPINE PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 OSB Lead-Long Term Study 08/12/2008 Progress Adequate
P870072
S037
THORATEC LABORATORIES CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 OSB Lead-Thoratec TLC-ii portable 11/14/2007 Progress Adequate
P100049 TORAX MEDICAL LINX REFLUX MANAGEMENT SYSTEM Gastroenterology/
Urology
03/22/2012 OSB Lead-Enrollment Study 06/22/2012 Progress Adequate
P120006 TRIVASCULAR INC OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 OSB Lead-Long Term Follow-up Study 06/21/2013 Progress Adequate
OSB Lead-Training Program 08/28/2013 Progress Adequate
P130018 UROMEDICA INC PROACT ADJUSTABLE INCONTINENCE THERAPY FOR MEN Gastroenterology/
Urology
11/24/2015 OSB Lead-ProAct Post-Approval Study Study Pending
P040050 UROPLASTY, LLC MACROPLASTIQUE IMPLANTS Gastroenterology/
Urology
10/30/2006 OSB Lead-5 year registry - ROSE 10/30/2006 Progress Adequate
P100014 VALEANT PHARMACEUTICALS NORTH AMERICA, LLC SOLESTA INJECTABLE GEL Gastroenterology/
Urology
05/27/2011 OSB Lead-Solesta - Long Term Study 02/26/2014 Progress Adequate
P140004 VERTIFLEX (R), INCORPORATED SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 ODE Lead-SPACER Progress Adequate
OSB Lead-Superion New Enrollment Study Progress Adequate
P050034 VISIONCARE, INC. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 OSB Lead-IMT PAS 01 New Enrollment Study 01/27/2015 Progress Inadequate
P040043
S051
W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 OSB Lead-Comprehensive/Linked-Registry Based Surv Progress Adequate
P160004 W. L. GORE & ASSOCIATES, INC. GORE TIGRIS VASCULAR STENT Cardiovascular 07/27/2016 ODE Lead-Continued F/u Study Study Pending
P020004
S123
W.L. GORE & ASSOCIATES,INC GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS Cardiovascular 02/29/2016 ODE Lead-Post-Approval Study Study Pending
P040037
S060
W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE Cardiovascular 09/19/2014 OSB Lead-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 OSB Lead-Longterm PAS 11/26/2008 Progress Adequate
H120003 XVIVO PERFUSION XPS WITH STEEN SOLUTION PERFUSATE Gastroenterology/
Urology
08/12/2014 OSB Lead-Long-Term Study 04/10/2015 Progress Inadequate
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 OSB Lead-Long Term Study 11/16/2016 Progress Inadequate
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 OSB Lead-Long term 06/28/2006 Revised/Replaced Study
P010030
S056
ZOLL MANUFACTURING CORPORATION LIFEVEST WEARABLE DEFIBRILLATOR Cardiovascular 12/17/2015 OSB Lead-PMA Post-Approval Study Progress Adequate


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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