• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             
To sort by data column: 248 orders  
  Active Orders
Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Sort By 522 Order Number Application
Number
Sort By 522 Order Number -- Descending
Sort By Manufacturer Application Sort By Manufacturer -- Descending
   Sort By Device Name Device
Name
Sort By Device Name -- Descending
Sort By Medical Specialty Medical
Specialty
Sort By Medical Specialty -- Descending
Sort By Date 522 Order Date PMA
Approved
Sort By Date 522 Order -- Descending
Study
Name
Date Original
Protocol
Accepted
Study Status
P160030 ABBOTT DIABETES CARE INC. Freestyle Libre Flash Glucose Monitoring System Clinical Chemistry 09/27/2017 OIR Lead-FreeStyle Libre Flash Glucose Monitoring Protocol Pending
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 Overdue
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 07/31/2015 Progress Adequate
P980040
S039
ABBOTT MEDICAL OPTICS INC TECNIS TORIC 1-PEICE INTRAOCULAR LENS Ophthalmic 04/15/2013 OSB Lead-New Enrollment of Post Approval Study 04/15/2013 Progress Adequate
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
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ODE Lead ABSORB IV Post-Approval Study 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
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 OSB Lead-Comprehensive/Linked-Registry Based Surv 10/24/2013 Progress Adequate
OSB Lead-New EnrollMitraClip Analysis Cohort (MAC) 10/24/2013 Progress Adequate
P140003 ABIOMED, INC. IMPELLA Cardiovascular 03/23/2015 OSB Lead-New Enrollment Study 11/13/2015 Progress Adequate
H140001 ABIOMED, INC. IMPELLA RP SYSTEM Cardiovascular 01/23/2015 OSB Lead-Impella RP Prospective Study 01/23/2015 Progress Adequate
OSB Lead-Impella RP Pediatric Study 01/23/2015 Progress Inadequate
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
S008
ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEM Cardiovascular 12/01/2016 OSB Lead-Impella PROTECTED PCI PAS cVAD Registry 08/22/2017 Study Pending
P170011 Abiomed, Inc. Impella RP System Cardiovascular 09/20/2017 OSB Lead-Impella RP-RWE Eval and Reporting 09/20/2017 Study Pending
OSB Lead-Impella RP Pediatric-RWE Eval and Report 09/20/2017 Study Pending
P120023 ACUFOCUS, INC. KAMRA INLAY Ophthalmic 04/17/2015 OSB Lead-New Enrollment Study 05/12/2016 Progress Adequate
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 ODE lead-AEGEA Pivotal Clinical Study Study Pending
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 ODE Lead-Post-Approval Clinical Study 06/11/2015 Progress Adequate
OSB Lead-Enhanced Safety Surveillance Study 06/11/2015 Progress Adequate
H070005 AGA MEDICAL CORP. THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER Cardiovascular 01/10/2017 OSB Lead-AMPLATZER PIVSD Occluder PAS 04/13/2017 Progress Adequate
P040040 AGA MEDICAL CORPORATION AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 OSB Lead-Post Approval Study 09/07/2007 Progress Inadequate
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 OSB Lead-CyPass Micro Stent New Enrollment PAS 03/15/2017 Progress Adequate
ODE Lead-COMPASS Extenstion Study 11/03/2016 Progress Adequate
P040020
S049
Alcon Research, Ltd. ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS Ophthalmic 12/22/2016 OSB Lead-AcrySof IQ ReSTOR +3.0 Toric PAS Protocol Overdue
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 OSB Lead-Natrelle and 410 Combined Cohort 02/20/2013 Progress Adequate
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 OSB Lead-BIFS (Large PAS) 11/17/2006 Revised/Replaced Study
OSB Lead-Re-Op Phase 01/16/2015 Progress Adequate
OSB Lead-Natrelle and 410 Combined Cohort 08/03/2015 Progress Adequate
P000008 APOLLO ENDOSURGERY INC LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology
06/05/2001 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 02/16/2011 Progress Inadequate
P140008 APOLLO ENDOSURGERY INC ORBERA INTRAGASTRIC BALLOON Gastroenterology/
Urology
08/05/2015 OSB Lead-ORBERA PAS (OPAS-001) 02/26/2016 Progress Inadequate
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology
06/14/2016 ODE Lead-PATHWAY Clinical Trial PAS Progress Adequate
OSB Lead-AspireAssist Post-Approval Study 12/15/2016 Progress Inadequate
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 OSB Lead-AtriCure Synergy Ablation System 12/14/2011 Progress Adequate
P070014
S022
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 OSB Lead-LifeStent SOLO 09/16/2011 Progress Adequate
P070014
S037
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 OSB Lead-Popliteal Indication PAS Surv Project 08/31/2016 Progress Adequate
P070014
S010
BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 OSB Lead-CONTINUUM Long Lesion 12/23/2010 Progress Adequate
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 OSB Lead-CONTINUUM 02/13/2009 Progress Adequate
P160024 BARD PERIPHERAL VASCULAR, INC. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT Cardiovascular 04/24/2017 ODE Lead-BOLSTER Continued f/u Study Progress Adequate
P030002
S027
Bausch & Lomb, Inc. TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 OSB Lead-New Enrollment Study 05/20/2013 Progress Adequate
P020014
S041
BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/29/2015 ODE Lead-Post Approval Study 07/29/2015 Progress Adequate
P020014
S017
BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
02/24/2012 OSB Lead-Essure/post-NovaSure PAS 02/24/2012 Progress Adequate
P970018
S033
BD Diagnostic Systems BD SUREPATH COLLECTION VIAL Pathology 12/02/2016 OIR Lead-Post-Approval Study Progress Adequate
P160035 Berlin Heart Inc. EXCOR Pediatric Ventricular Assist Device Cardiovascular 06/06/2017 OSB Lead-Berlin Heart Comprehensive Reg Based Surv Protocol Pending
H100004 Berlin Heart Inc. EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE Cardiovascular 12/16/2011 OSB Lead-All Comers Registry 12/16/2011 Progress Adequate
P000018 BEST VASCULAR, INC BETA-CATH (TM) SYSTEM Cardiovascular 11/03/2000 OSB Lead-Beta-Cath Long Term 11/03/2000 Progress Inadequate
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 OSB Lead-Long Term PAS 04/21/2004 Progress Adequate
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 ODE Lead-Extended f/u of Premarket Cohort 03/16/2016 Progress Adequate
P030031
S011
BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 OSB Lead-CABANA Trial 11/24/2009 Progress Adequate
OSB Lead-Atrial Fibrillation Registry 08/12/2009 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 05/12/2008 Progress Adequate
P050023
S076
BIOTRONIK, INC. ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D Cardiovascular 07/03/2014 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
P070008
S079
BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 ODE Lead-QP ExCELS Sentus QP Ext CRT w/ Quad LV Study Pending
P050023
S107
BIOTRONIK, INC. Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization Cardiovascular 05/06/2017 OSB Lead-MPP QP-ExCELs Sub-Study PAS Study Pending
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 OSB Lead-ProMRI ICD/CRT-D System 07/21/2017 Progress Adequate
P160003 BIOTRONIK, INC. PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM Cardiovascular 02/14/2017 ODE Lead-Extended Study of Premarket Cohort Progress Adequate
P160025 BIOTRONIK, INC. ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM Cardiovascular 03/23/2017 ODE Lead-BIOFLEX-I PAS 03/23/2017 Study Pending
P950037
S156
BIOTRONIK, INC. SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60 Cardiovascular 06/08/2016 ODE Lead-Siello Pacing Lead Study Progress Adequate
P050023
S087
BIOTRONIK, INC. IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4) Cardiovascular 12/21/2015 OSB Lead-ProMRI ICD Post-Approval Study 06/16/2016 Progress Adequate
P050023
S094
BIOTRONIK, INC. IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) Cardiovascular 05/02/2016 OSB Lead-ProMRI ICD/CRT-D System Home Monitorin 08/01/2016 Progress Adequate
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 09/21/2012 Progress Inadequate
P910073
S077
BOSTON SCIENTIFIC ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 11/10/2010 Progress Adequate
P960040
S198
BOSTON SCIENTIFIC TELIGEN 4-SITE MODELS Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 11/10/2010 Progress Adequate
P960040
S385
BOSTON SCIENTIFIC NG4 Family of Pulse Generators ICDS. Cardiovascular 05/02/2017 OSB Lead-SMART-MSP PAS 08/07/2017 Study Pending
OSB Lead-MANAGE-HF 07/25/2017 Progress Adequate
P010012
S436
Boston Scientific Corp. NG4 Family of Pulse Generators CRT-DS Cardiovascular 05/02/2017 OSB Lead-SMART-MSP PAS 08/07/2017 Study Pending
OSB Lead-MANAGE-HF 07/25/2017 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
P010012
S212
Boston Scientific Corp. COGNIS 4-SITE MODELS Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 11/10/2010 Progress Adequate
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 OSB Lead-New Patient Study 04/27/2010 Progress Adequate
P010012
S230
Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 OSB Lead-MADIT-CRT ACC NCDR 09/16/2010 Progress Adequate
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 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 06/01/2012 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 11/22/2011 Progress Adequate
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 OSB Lead-WATCHMAN Comprehensive/Linked-Registry 03/18/2016 Progress Adequate
ODE Lead-Continued f/u of IDE Cohorts Progress Adequate
OSB Lead-WATCHMAN New Enrollment (NESTed-PAS) 11/21/2016 Revised/Replaced Study
P110042 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 OSB Lead-S-ICD PAS Registry 09/28/2012 Progress Adequate
P110042
S058
BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 08/08/2016 OSB Lead-EMBLEM MRI S-ICD Pt Mgmt System Surv 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 Progress Adequate
P110042
S077
BOSTON SCIENTIFIC CORPORATION Model 3501 EMBLEM S-ICD subcutaneous Electrode Cardiovascular 09/29/2017 OSB Lead-EMBLEM S-ICD Electrode Model 3501 PAS Study Pending
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 Inadequate
P150017 Cartiva, Inc CARTIVA SYNTHETIC CARTILAGE IMPLANT Orthopedic 07/01/2016 ODE Lead MOTION Extend Study Progress Adequate
P160014 CELONOVA BIOSCIENCES, INC. COBRA PzF NanoCoated Coronary Stent System Cardiovascular 02/21/2017 ODE Lead-Cont f/u of PzF SHIELD IDE Cohort Study Pending
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 ODE Lead-Post-Approval Study 03/17/2016 Progress Adequate
P130016 Cochlear Americas NUCLEUS HYBRID L24 IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 OSB Lead-Extended f/u study 03/20/2014 Progress Adequate
OSB Lead-New Enrollment Study 03/20/2014 Progress Adequate
P890055
S026
CODMAN CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 OSB Lead-Leachables Study 12/17/2010 Progress Adequate
OSB Lead-Drug Stability Study 12/17/2010 Progress Adequate
P100022 COOK MEDICAL INCORPORATED ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 OSB Lead-New US Enrollment 11/14/2012 Progress Adequate
OSB Lead-Zilver PTX Stent PAS 11/14/2012 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 04/04/2012 Progress Adequate
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 OSB Lead-Long Term Study 07/03/2007 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 12/23/2010 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 04/02/2013 Progress Adequate
OSB Lead-Short-Mid-Term F/u of New COC36 patients 04/02/2013 Progress Inadequate
OSB Lead-COC36 PAS: UK & Australian Natl Joint Reg 04/02/2013 Progress Adequate
P120005
S041
DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 12/20/2016 OIR Lead-Post-Approval Study 12/20/2016 Progress Adequate
P110014 DUNE MEDICAL DEVICES INC DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery
12/27/2012 OSB Lead-MarginProbe System US PAS 12/27/2012 Progress Inadequate
P110021 EDWARDS LIFESCIENCES LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/19/2012 OSB Lead-Newly Enrolled Study 10/19/2012 Progress Adequate
P100041 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 11/02/2011 OSB Lead-Newly Enrolled Study 11/02/2011 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) 06/16/2014 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 12/05/2008 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
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-Comprehensive/Linked-Registry Based Surv Study Pending
P150048 EDWARDS LIFESCIENCES, LLC. EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 06/29/2017 ODE Lead-PAS Continued Follow-up 07/29/2017 Study Pending
OSB Lead-Model 11500A Prospective PAS Protocol Pending
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 ODE Lead-Continued f/u of premarket cohort 06/17/2015 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Study Pending
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 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 10/09/2015 Progress Adequate
OSB Lead-Comprehensive Linked Registry-Based Surv Progress Adequate
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 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Based Surv Study Pending
P140031
S028
EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/05/2017 OSB Lead-SAPIEN 3 Mitral Valve-in-Valve Comp Surv 11/20/2017 Study Pending
OSB Lead-SAPIEN 3 Aortic Valve-in-Valve Comp Surv 11/20/2017 Study Pending
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 OSB Lead-New Enrollment 03/17/2010 Revised/Replaced Study
OSB Lead-Esteem New Enrollment 2 04/16/2010 Progress Inadequate
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 OSB Lead-Epi proColon PAS 10/18/2016 Progress Adequate
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 OSB Lead-Cologuard PAS 02/02/2015 Progress Adequate
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 OSB Lead-Novation PAS 07/05/2007 Progress Adequate
OSB Lead-Long Term 07/05/2007 Revised/Replaced Study
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 OSB Lead-Prometra Programmable Pump system 05/03/2012 Progress Inadequate
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 06/25/2012 Progress Adequate
OSB Lead-Registry Study 06/25/2012 Revised/Replaced Study
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 OSB Lead-Enhanced Surveillance 09/28/2012 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 02/01/2013 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 10/18/2012 Progress Adequate
P150038 InSightec EXABLATE Neurology 07/11/2016 ODE Lead-Long Term PAS 09/29/2016 Progress Adequate
P040003
S015
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
08/31/2015 OSB Lead-Post ExAblate Pregnancy Outcomes Registry 08/31/2015 Progress Inadequate
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 04/30/2014 Progress Inadequate
P000057 INTEGRA LIFESCIENCES CORPORATION ASCENSION MCP Orthopedic 11/19/2001 OSB Lead-Ascension MCPT 11/19/2001 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 10/10/2013 Progress Adequate
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 Adequate
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 05/16/2014 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 08/23/2013 Progress Adequate
OSB Lead-Enhanced Surveillance System 08/23/2013 Progress Adequate
OSB Lead-Retrieval Analysis 08/23/2013 Progress Adequate
P060038
S017
LivaNova Canada Corp. MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL Cardiovascular 04/18/2014 OSB Lead-NEMO PAS 07/15/2014 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) 10/09/2014 Progress Inadequate
P130024
S009
LUTONIX LUTONIX 035 DRUG COATED BALLOON PTA CATHETER Cardiovascular 02/07/2017 ODE Lead-ISR and LL Cohorts of the Global SFA Reg Progress Adequate
ODE Lead-SFA ISR IDE Continued f/u study Progress Adequate
ODE Lead-Lutonix Long Lesion SFA Cont f/u study Progress Adequate
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 ODE Lead-IDE Cohort Post Approval Study Study Pending
OSB Lead-New Enrollment PAS Registry Protocol Pending
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 12/08/2016 Progress Adequate
P030006 MEDIFOCUS, INC PROLIEVE THERMODILATATION SYSTEM Gastroenterology/
Urology
02/19/2004 OSB Lead-Prolieve PAS 02/19/2004 Progress Adequate
P170008 Medinol, Ltd. EluNIR™ Ridaforolimus Eluting Coronary Stent System Cardiovascular 11/28/2017 ODE Lead-Cont f/u of BIONICS Clinical Study 11/28/2017 Progress Adequate
P100047
S090
Medtronic HeartWare™ HVAD™ System Cardiovascular 09/27/2017 ODE Lead-Cont F/u of HW004-A ENDURANCE Protocol Pending
OSB Lead-ENDURANCE PAS Protocol Pending
P100047 Medtronic HEARTWARE VENTRICULAR ASSIST SYSTEM Cardiovascular 11/20/2012 OSB Lead-Newly Enrolled (HW-PAS-01) 11/20/2012 Progress Adequate
OSB Lead-Training Program (HeartWare-PAS-02) 11/20/2012 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 04/04/2012 Progress Adequate
OSB Lead-REVERSE Product Surveillance Registry 04/04/2012 Progress Inadequate
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 01/09/2012 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 01/09/2012 Progress Adequate
P830061
S129
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574. Cardiovascular 10/12/2016 OSB Lead-MR conditional Tachy Therapy Systems 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-PCT Change Study 04/01/2016 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
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
S014
MEDTRONIC COREVALVE LLC COREVALVE (TM) EVOLUT(TM) R SYSTEM Cardiovascular 06/22/2015 ODE Lead-Continued f/u of premarket cohort Study Pending
OSB Lead-Comprehensive/Linked-Registry Based Surv Study Pending
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
S033
MEDTRONIC COREVALVE LLC CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System Cardiovascular 07/10/2017 ODE Lead-Cont f/u Intermediate Risk Cohort Study Pending
OSB Lead-Intermediate Risk Surveillance Protocol Pending
P130021
S025
MEDTRONIC COREVALVE LLC Medtronic CoreValve Evolut R XL system Cardiovascular 10/26/2016 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 01/17/2014 Revised/Replaced Study
ODE Lead-Continued f/u of continued access cohort 01/17/2014 Revised/Replaced Study
P130021
S002
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 OSB 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 12/17/2010 Progress Adequate
P920015
S055
MEDTRONIC Inc. MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 01/09/2012 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 03/31/2011 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 06/13/2008 Progress Adequate
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 09/26/2013 Revised/Replaced Study
OSB Lead-PAS of TS Feat w/sensor-aug w/comm data 10/11/2017 Study Pending
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
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
P140017 MEDTRONIC Inc. MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) Cardiovascular 01/27/2015 OSB Lead-New Enrollment Study 01/27/2015 Progress Adequate
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
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
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
P920015
S163
MEDTRONIC Inc. SPRINT QUATTRO SECURE S MRI SURESCAN ; SPRINT QUATTRO SECURE MRI SURESCAN Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P980035
S442
MEDTRONIC Inc. ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE Cardiovascular 04/28/2016 OSB Lead-PCT Change Study 04/01/2016 Progress Adequate
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-PCT Change Study 04/01/2016 Progress Adequate
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 ODE Lead-Micra Rate Resp Conf Study 03/08/2016 Progress Adequate
OSB Lead-Micra Transcatheter Pacing System PAS 03/08/2016 Progress Adequate
P140010
S015
MEDTRONIC Inc. IN PACT(TM) ADMIRAL(TM) PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 09/07/2016 OSB Lead-Surveillance Post Market Registry 12/06/2016 Progress Adequate
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 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P160017 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 09/28/2016 OIR Lead-Post Approval Study 12/22/2016 Progress Adequate
P970004
S022
MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology
09/24/2002 OSB Lead-Urgency Frequency (UF 1635) 09/24/2002 Revised/Replaced Study
OSB Lead-Urinary Urge Incontinence (UUI) 09/24/2002 Revised/Replaced Study
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 Revised/Replaced Study
OSB Lead-Device Failure 03/11/2016 Revised/Replaced Study
P090029
S006
Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 12/15/2016 ODE Lead-Device Failure and Complaint Analysis 12/15/2016 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 Progress Adequate
OSB Lead-PRESTIGE LP 2-Level Metal Concentrations Progress Inadequate
P160043 MEDTRONIC VASCULAR RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 04/28/2017 ODE Lead-Cont f/u RESOLUTE ONYX Clinical Study Pending
ODE Lead-RESOLUTE ONYX PAS Study Pending
P100021
S063
Medtronic Vascular Edurant II/IIs Stent Graft System Cardiovascular 09/29/2017 ODE Lead-Cont f/u ANCHOR Reg Short Neck Cohort 09/29/2017 Progress Adequate
P160043
S001
MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 11/16/2017 ODE Lead-Cont f/u of RESOLUTE ONYX 2.0 Clinical Study Pending
ODE Lead-RESOLUTE ONYX PAS Study Pending
P110013
S005
Medtronic Vascular RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/22/2013 OSB Lead-Resolute Integrity PAS Newly Enrolled 02/22/2013 Progress Adequate
OSB Lead-Continued F/u of Premarket and OUS Cohort 02/22/2013 Progress Adequate
P100021 Medtronic Vascular MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM Cardiovascular 12/16/2010 OSB Lead-ENGAGE 05/09/2011 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. 06/23/2014 Progress Adequate
P110023 MEDTRONIC VASCULAR INC EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Cardiovascular 03/07/2012 OSB Lead-Durability II PAS 03/07/2012 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
S225
Medtronic, Inc CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI Cardiovascular 10/12/2016 OSB Lead-MR conditional Tachy Therapy Systems Stud Progress Adequate
P090013
S205
Medtronic, Inc CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI Cardiovascular 04/28/2016 OSB Lead-PCT Change Study 04/01/2016 Progress Adequate
P090013
S202
Medtronic, Inc CAPSUREFIX MRI SURESCAN Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P930039
S142
Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 Cardiovascular 04/28/2016 OSB Lead-PCT Change Study 04/01/2016 Progress Adequate
P930039
S140
Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Progress Adequate
P890003
S338
Medtronic, Inc. CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS MONITOR Cardiovascular 02/01/2016 OSB Lead-MR conditional Tachy Therapy Systems Stud Progress Adequate
P930039
S151
Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 Cardiovascular 10/12/2016 OSB Lead-MR conditional Tachy Therapys Systems Progress Adequate
P890003
S329
Medtronic, Inc. CARELINK MONITOR AND EXPRESS MONITOR, CARDIOSIGHT READER; CARELINK EXPRESS Cardiovascular 09/11/2015 OSB Lead-Evera MRI System PAS Study Pending
P890003
S179
Medtronic, Inc. CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 01/09/2012 Progress Adequate
P890003
S252
Medtronic, Inc. CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER Cardiovascular 01/15/2013 OSB Lead-SureScan Pacing System 01/15/2013 Progress Adequate
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 OSB Lead-MemoryGel and Shape Glow Study 10/01/2014 Progress Adequate
OSB Lead-Large PAS 05/17/2007 Revised/Replaced Study
OSB Lead-Re-Op Phase 01/16/2015 Progress Adequate
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery
06/14/2013 OSB Lead-MemoryGel and Shape Glow Study 06/14/2013 Progress Adequate
P040047 MERZ NORTH AMERICA, INC COAPTITE Gastroenterology/
Urology
11/10/2005 OSB Lead-Coaptite 11/10/2005 Progress Adequate
P050052
S049
MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
06/04/2015 OSB Lead-Radiesse Radiological Evaluation Study 09/02/2015 Progress Adequate
OSB Lead-Radiesse New Enrollment Study 11/23/2015 Progress Adequate
P100018 MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE Neurology 04/06/2011 OSB Lead-Continued Follow-up of Premarket Cohort 04/06/2011 Progress Adequate
P140013 MINERVA SURGICAL MINERVA ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
07/27/2015 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 01/14/2010 Progress Adequate
P010047
S010
NEOMEND, INC. NEOMEND PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 12/21/2011 OSB Lead-NeoMend ProGel Pleural Air Leak Sealant 12/21/2011 Progress Adequate
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 OSB Lead-Continued F/u -Long Term Treatment (LTT) 11/14/2013 Progress Adequate
OSB Lead-New Enrollment - All Comers 11/14/2013 Progress Inadequate
OSB Lead-New Enrollment -Performance & Programming 11/14/2013 Progress Inadequate
OSB Lead-Lead Extraction Study 11/14/2013 Progress Adequate
OSB Lead-Autopsy Study 11/14/2013 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 04/08/2011 Revised/Replaced Study
P150028 NUMED, INC. CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) Cardiovascular 03/25/2016 ODE Lead-Continued f/u of Premarket Cohorts 03/25/2016 Progress Adequate
ODE Lead-Cont f/u of premarket cohorts w/stent fra 03/25/2016 Progress Adequate
P100012 NUVASIVE, INC. NUVASIVE PCM CERVICAL DISC SYSTEM Orthopedic 10/26/2012 OSB Lead-PCM Cervical Enhanced Surveillance 10/26/2012 Progress Adequate
OSB Lead-PCM Cervical Long Term 10/26/2012 Progress Adequate
P160001 OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM Gastroenterology/
Urology
09/08/2016 OSB Lead-Obalon Balloon System PAS 07/19/2017 Progress Adequate
P160001
S003
OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM Gastroenterology/
Urology
04/25/2017 OSB Lead-Obalon Balloon System PAS 07/19/2017 Progress Adequate
P130004 OCULAR THERAPEUTICS, INC. RESURE SEALANT Ophthalmic 01/08/2014 OSB Lead-Device Exposure Registry Study 01/08/2014 Progress Inadequate
P000037
S030
On-X Life Technologies, Inc. ON-X PROSTHETIC HEART VALVE Cardiovascular 04/01/2015 OSB Lead-Newly Enrolled On-X PAS 06/19/2015 Progress Adequate
P110008 PARADIGM SPINE, LLC COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 OSB Lead-Coflex Actual Practice PAS USA 08/05/2015 Progress Inadequate
OSB Lead-Coflex Actual Practice PAS 10/17/2012 Revised/Replaced Study
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 OSB Lead-Nit-Occlud PDA PAS 08/16/2013 Progress Adequate
H160002 PULSAR VASCULAR, INC PulseRider Aneurysm Neck Reconstruction Device Neurology 06/19/2017 ODE Lead-ANSWER Clinical Study Progress Adequate
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology
11/18/2011 OSB Lead-Registry Study 11/18/2011 Progress Inadequate
OSB Lead-Deep Hyperthermia and Radiation 11/18/2011 Revised/Replaced Study
OSB Lead-Enhanced Surveillance Study 11/18/2011 Progress Inadequate
P030050
S002
Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 OSB Lead-Clinical PAS 07/28/2009 Progress Adequate
P130019 ReShape Lifesciences, Inc. MAESTRO RECHARGEABLE SYSTEM Gastroenterology/
Urology
01/14/2015 ODE Lead-Extended F/u of Premarket Cohort 06/02/2015 Progress Adequate
OSB Lead-New Enrollment Study 07/24/2015 Progress Inadequate
P140012 RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM Gastroenterology/
Urology
07/28/2015 OSB Lead-REDUCE PAS 01/14/2016 Progress Inadequate
P160039 RESPICARDIA remede® System Anesthesiology 10/06/2017 ODE Lead-Post-Approval Study Protocol Pending
P150034 REVISION OPTICS, INCORPORATED Raindrop Near Vision Inlay Ophthalmic 06/29/2016 ODE Lead Post-Approval Study 12/27/2016 Progress Inadequate
OSB Lead-Raindrop Near Vision Inlay New Enrollment Protocol Overdue
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 02/13/2013 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) 03/09/2012 Progress Adequate
OSB Lead-Post-Approval PMA Cohorts Study (PACS) 03/09/2012 Progress Adequate
P140026 SILK ROAD MEDICAL, INC ENROUTE TRANSCAROTID STENT SYSTEM Cardiovascular 05/18/2015 OSB Lead-ROADSTER 2 Registry 08/03/2015 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 Progress Inadequate
OSB Lead-Short to Mid-Term f/u of New US Patients 10/17/2016 Study Pending
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 OSB Lead-US Study 05/09/2006 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 11/29/2011 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 05/28/2014 Progress Adequate
P130026 St. Jude Medical TACTICATH QUARTZ SET Cardiovascular 10/24/2014 OSB Lead-TactiCath Quartz PAS 08/20/2014 Progress Adequate
P150004 St. Jude Medical Axium Neurostimulator System Neurology 02/11/2016 OSB Lead-F/U Axium Neurostimulator System (FANS) 05/26/2016 Progress Adequate
P140033 St. Jude Medical, Inc. Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software Cardiovascular 01/31/2017 OSB Lead-SJM Brady MRI PAS 01/31/2017 Progress Adequate
P120021 St. Jude Medical, Inc. AMPLATZER PFO OCCLUDER Cardiovascular 10/28/2016 OSB Lead-Amplatzer PFO Occluder New Enrollment PAS 09/22/2017 Study 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
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 OSB Lead-Long term 05/12/2006 Revised/Replaced Study
P050050 STRYKER CORPORATION SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 OSB Lead-Long Term Study 05/27/2009 Progress Adequate
OSB Lead-Actual Conditions of Use Study (STAR 2) 05/27/2009 Progress Adequate
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 05/16/2012 Progress Adequate
OSB Lead-Enhanced Surveillance 05/16/2012 Revised/Replaced Study
P070001 SYNTHES SPINE PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 OSB Lead-Long Term Study 12/17/2007 Progress Adequate
P160049 The Spectranetics Corp. STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON Cardiovascular 07/26/2017 ODE Lead-ILLUMINATE Continued Follow-Up Study 07/26/2017 Study Pending
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 03/22/2012 Progress Adequate
P120006 TRIVASCULAR INC OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 OSB Lead-Long Term Follow-up Study 10/05/2012 Progress Adequate
P150039 TRYTON MEDICAL, INC. TRYTON SIDE BRANCH STENT Cardiovascular 02/21/2017 ODE Lead-TRYTON Side Branch Stent PIVOTAL RCT 02/21/2017 Progress Adequate
ODE Lead-TRYTON Side Branch Stent EA Confirmatory 02/21/2017 Progress Adequate
OSB Lead-TRYTON Side Branch New Enrollment Study 07/13/2017 Progress Adequate
P130018 UROMEDICA INC PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN Gastroenterology/
Urology
11/24/2015 OSB Lead-ProAct Post-Approval Study 11/02/2016 Progress Adequate
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 05/27/2011 Progress Adequate
P140004 VERTIFLEX (R), INCORPORATED SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 ODE Lead-SPACER 11/18/2015 Progress Adequate
OSB Lead-Superion New Enrollment Study 12/15/2015 Progress Inadequate
P050034 VISIONCARE, INC. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 OSB Lead-IMT PAS 01 New Enrollment Study 07/01/2010 Progress Inadequate
P040043
S051
W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 OSB Lead-Comprehensive/Linked-Registry Based Surv 06/23/2014 Progress Adequate
P160021 W. L. Gore & Associates, Inc. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS Cardiovascular 01/27/2017 ODE Lead-VBX FLEX Continued f/u Study Progress Adequate
P160004 W. L. GORE & ASSOCIATES, INC. GORE TIGRIS VASCULAR STENT Cardiovascular 07/27/2016 ODE Lead-Continued F/u Study Progress Adequate
P020004
S123
W.L. GORE & ASSOCIATES,INC GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS Cardiovascular 02/29/2016 ODE Lead-Post-Approval Study Progress Adequate
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
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology
05/12/2017 OSB Lead-Flourish Post-Approval Study Protocol Pending
H120003 XVIVO PERFUSION XPS WITH STEEN SOLUTION PERFUSATE Gastroenterology/
Urology
08/12/2014 OSB Lead-Long-Term Study 04/10/2015 Progress Adequate
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 OSB Lead-Long Term Study 11/06/2008 Progress Inadequate
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 OSB Lead-Long term 06/28/2006 Revised/Replaced Study


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

Related Links

-
-