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U.S. Department of Health and Human Services

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

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Study
Name
Date Original
Protocol
Accepted
Study Status
P170038 Abbott CentriMag Circulatory Support System Cardiovascular 12/06/2019 CentriMag FTW PAS 05/22/2020 Study Pending
P160030 ABBOTT DIABETES CARE INC. Freestyle Libre Flash Glucose Monitoring System Clinical Chemistry 09/27/2017 FreeStyle Libre Flash Glucose Monitoring 12/08/2017 Progress Adequate
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study 09/07/2007 Progress Inadequate
H070005 Abbott Medical THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER Cardiovascular 01/10/2017 AMPLATZER PIVSD Occluder PAS 04/13/2017 Progress Adequate
P120021 Abbott Medical AMPLATZER PFO OCCLUDER Cardiovascular 10/28/2016 Amplatzer PFO Occluder New Enrollment PAS 09/22/2017 Progress Adequate
P150004 Abbott Medical Axium Neurostimulator System Neurology 02/11/2016 F/U Axium Neurostimulator System (FANS) 05/26/2016 Progress Adequate
P020024
S052 		Abbott Medical AMPLATZER Piccolo Occluder Cardiovascular 01/11/2019 Continued FU of IDE/CAP cohort 01/11/2019 Progress Adequate
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 Comprehensive/Linked-Registry Based Surv 10/24/2013 Progress Adequate
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ABSORB IV Post-Approval Study Progress Adequate
P100009
S028 		ABBOTT VASCULAR INC. MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System Cardiovascular 03/14/2019 Cont f/u of the COAPT Trival Pivotal Cohort Progress Adequate
Registry-Based CAP Cohort and RWU Surveillances 07/26/2019 Progress Adequate
P140003 ABIOMED, INC. IMPELLA 2.5 System Cardiovascular 03/23/2015 New Enrollment Study 11/13/2015 Revised/Replaced Study
P140003
S004 		ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEMS Cardiovascular 04/07/2016 Impella AMI CS PAS 08/09/2016 Progress Adequate
P140003
S005 		ABIOMED, INC. IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM Cardiovascular 04/07/2016 Impella PCCS PAS 08/09/2016 Progress Adequate
P140003
S008 		ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEM Cardiovascular 12/01/2016 Impella PROTECTED PCI PAS cVAD Registry 08/22/2017 Progress Adequate
P170011 Abiomed, Inc. Impella RP System Cardiovascular 09/20/2017 Impella RP-RWE Eval and Reporting 09/20/2017 Progress Adequate
Impella RP Pediatric-RWE Eval and Report 09/20/2017 Progress Adequate
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Enhanced Safety Surveillance Study 06/11/2015 Progress Adequate
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 CyPass Micro Stent New Enrollment PAS 03/15/2017 Progress Adequate
COMPASS XXT Post-Approval Study 04/09/2020 Progress Adequate
P040020
S049 		Alcon Research, Ltd. ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS Ophthalmic 12/22/2016 AcrySof IQ ReSTOR +3.0 Toric PAS 10/11/2018 Study Pending
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery		 11/17/2006 Natrelle and 410 Combined Cohort 08/03/2015 Progress Inadequate
BIFS (Large PAS) 11/17/2006 Revised/Replaced Study
Re-Op Phase 01/16/2015 Progress Inadequate
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery		 02/20/2013 Natrelle and 410 Combined Cohort 02/20/2013 Progress Inadequate
P930016
S053 		AMO Manufacturing USA, LLC iDESIGNRefractive Studio, STAR Excimer Laser System Ophthalmic 06/15/2018 Post-Approval Study 01/29/2019 Progress Adequate
P150009 ANGEL MEDICAL SYSTEMS INC. ANGELMED GUARDIAN SYSTEM Cardiovascular 04/09/2018 AngelMed Guardian PAS 08/14/2018 Study Pending
H170001 ApiFix, Ltd. Minimally Invasive Deformity Correction (MID-C) System Orthopedic 08/23/2019 MID-C System Registry PAS 10/23/2019 Study Pending
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology		 06/14/2016 AspireAssist Post-Approval Study 12/15/2016 Progress Inadequate
P070014
S037 		BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 Popliteal Indication PAS Surv Project 08/31/2016 Progress Adequate
P180037 Bard Peripheral Vascular, Inc. Venovo Venous Stent System Cardiovascular 03/13/2019 VERNACULAR Cont F/u PAS Study Pending
P030002
S027 		Bausch & Lomb, Inc. TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 New Enrollment Study 05/20/2013 Progress Adequate
P020014
S017 		BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology		 02/24/2012 Essure/post-NovaSure PAS 02/24/2012 Progress Adequate
P020014
S041 		BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology		 06/29/2015 Post Approval Study 07/29/2015 Progress Adequate
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 Long Term PAS 04/21/2004 Progress Adequate
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 Extended f/u of Premarket Cohort 03/16/2016 Progress Adequate
P100006
S005 		BIOMIMETIC THERAPEUTICS,LLC AUGMENT INJECTABLE Orthopedic 06/12/2018 Long-term PAS 06/11/2019 Progress Adequate
P030031
S086 		BIOSENSE WEBSTER, INC. Visitag Surpoint External Processing Unit (EPU) Cardiovascular 06/01/2018 VISITAG SURPOINT PAS Progress Adequate
P030031
S100 		BIOSENSE WEBSTER, INC. THERMOCOOL SMARTTOUCH® SF Catheter Cardiovascular 09/30/2020 Real-World Experience of Catheter Ablation of PsAF Protocol Pending
P170030 Biotronik, Inc ORSIRO Sirolimus Eluting Coronary Stent System Cardiovascular 02/22/2019 ORSIRO PAS 11/12/2019 Progress Adequate
P050023
S076 		BIOTRONIK, INC. ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P980023
S057 		BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P950037
S156 		BIOTRONIK, INC. SIELLO S 45, SIELLO S 53,SIELLO S 60,SOLIA S45,SOLIA S 53,SOLIA S60 Cardiovascular 06/08/2016 Siello Pacing Lead Study 06/08/2016 Progress Adequate
P070008
S079 		BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/ Quad LV Progress Adequate
P050023
S105 		BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/Quad LV Progress Adequate
P190015 Bolton Medical Inc. TREO® Abdominal Stent-Graft System Cardiovascular 05/04/2020 Cont F/u of the IDE Study Subjects 05/04/2020 Study Pending
TREO Post Approval Study 07/31/2020 Progress Adequate
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 Relay Thoracic Stent-Graft w Plus Del Sys 09/21/2012 Progress Adequate
P960040
S385 		BOSTON SCIENTIFIC NG4 Family of Pulse Generators ICDS. Cardiovascular 05/02/2017 MANAGE-HF 07/25/2017 Progress Adequate
SMART-MSP PAS 08/07/2017 Progress Adequate
P910073
S145 		BOSTON SCIENTIFIC Reliance 4- Front Lead Family and Suture Sleeve Accessory Cardiovascular 05/04/2018 NAVIGATE X4 PAS 05/04/2018 Progress Adequate
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 Fatigue & Stability Testing 10/10/2008 Progress Adequate
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 New Patient Study 04/27/2010 Progress Adequate
P010012
S230 		Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 MADIT-CRT ACC NCDR 09/16/2010 Progress Adequate
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 WATCHMAN Comprehensive/Linked-Registry 03/18/2016 Progress Adequate
Continued f/u of IDE Cohorts Progress Adequate
WATCHMAN New Enrollment (NESTed-PAS) 11/21/2016 Revised/Replaced Study
P010012
S398 		Boston Scientific Corp. ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE Cardiovascular 02/22/2016 ACUITY X4 Post Approval Study 02/22/2016 Progress Adequate
P010012
S436 		Boston Scientific Corp. NG4 Family of Pulse Generators CRT-DS Cardiovascular 05/02/2017 MANAGE-HF 07/25/2017 Progress Adequate
SMART-MSP PAS 08/07/2017 Progress Adequate
P150005
S014 		Boston Scientific Corp. Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter Cardiovascular 12/21/2017 Zero-AF PAS 11/01/2018 Progress Adequate
P150005
S035 		Boston Scientific Corp. Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters Cardiovascular 08/01/2018 INTERRUPT AF PAS 11/01/2018 Progress Adequate
P180011 Boston Scientific Corp. Eluvia Drug-Eluting Vascular Stent System Cardiovascular 09/18/2018 IMPERIAL Continued f/u study 09/18/2018 Progress Adequate
REGAL and EMINENT Long Term f/u studies 09/18/2018 Progress Adequate
P150005
S049 		Boston Scientific Corp. IntellaNav MiFi Open-Irrigated Ablation Catheter Cardiovascular 04/17/2020 DirectSense RF Sub-study 05/29/2020 Study Pending
P110042 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 S-ICD PAS Registry 09/28/2012 Progress Adequate
P110042
S077 		BOSTON SCIENTIFIC CORPORATION Model 3501 EMBLEM S-ICD subcutaneous Electrode Cardiovascular 09/29/2017 EMBLEM S-ICD Electrode Model 3501 PAS Progress Adequate
P150003
S039 		BOSTON SCIENTIFIC CORPORATION SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Cardiovascular 10/18/2018 EVOLVE 4.5/5.0 Study 03/29/2019 Progress Adequate
P180013 Boston Scientific Corporation VICI VENOUS STENT System Cardiovascular 05/02/2019 VIRTUS Continued Follow-up Study 05/02/2019 Progress Adequate
P180029 Boston Scientific Corporation LOTUS Edge Valve System Cardiovascular 04/23/2019 Cont F/u of REPRISE III Trial Premarket Cohorts 07/22/2019 Progress Adequate
RWU of LOTUS Edge Valve System 12/06/2019 Progress Adequate
P190019 Boston Scientific Corporation Ranger™ Paclitaxel-Coated PTA Balloon Catheter Cardiovascular 10/30/2020 RANGER II SFA Cont F/u Study Protocol Pending
Range Long Balloon, Ranger China & COMPARE I f/u Protocol Pending
P140004 Boston Scientific Neuromodulation SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 Superion New Enrollment Study 12/15/2015 Progress Inadequate
P150012
S083 		BOSTONSCIENTIFIC Ingevity + Lead - Active Fixation Cardiovascular 12/16/2019 INGEVITY+ Post Approval Study 12/16/2019 Progress Adequate
P170042
S002 		C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 03/01/2019 AVeNEW Study 10/31/2019 Progress Adequate
COVERA Post Approval Study 10/31/2019 Progress Adequate
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 PAS of HeartLight Endoscopic Ablation Sys Progress Adequate
P150026
S002 		CARDIOFOCUS, INC. Heart Light Catheter with Excalibur Balloon Cardiovascular 05/02/2018 CF HeartLight PAS Progress Adequate
P150026
S008 		CARDIOFOCUS, INC. HeartLight Endoscopic Ablation System Cardiovascular 05/08/2020 HeartLight X3 PAS 07/01/2020 Progress Adequate
P150040
S003 		Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser Ophthalmic 10/04/2018 VisuMax SMILE New Enrollment 07/25/2019 Progress Adequate
P160014 CELONOVA BIOSCIENCES, INC. COBRA PzF NanoCoated Coronary Stent System Cardiovascular 02/21/2017 Cont f/u of PzF SHIELD IDE Cohort Progress Adequate
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 Post-Approval Study 03/17/2016 Progress Adequate
P180032 Channel Medsystems, Inc. Cerene® Cryotherapy Device Obstetrics/
Gynecology		 03/28/2019 CLARITY Clinical Post-Approval Study Progress Adequate
P130016 Cochlear Americas NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 New Enrollment Study 03/20/2014 Progress Adequate
P970051
S172 		Cochlear Americas NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/17/2020 Nucleus 24 Pediatric Post-Approval Study 05/15/2020 Progress Adequate
P100022 Cook Ireland, Ltd. ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 Zilver PTX Stent PAS 11/14/2012 Progress Adequate
P140016 COOK MEDICAL INCORPORATED ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT Cardiovascular 09/15/2015 Post-Approval Study Progress Adequate
P020018
S040 		COOK, INC. ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 Long Term F/U Study 04/04/2012 Progress Adequate
P180035 CooperVision, Inc. MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Ophthalmic 11/15/2019 MiSight 1 Day PAS Protocol Pending
MiSight 1 Day Safety PAS Protocol Pending
P150002 Cordis Corporation INCRAFT(R) AAA STENT GRAFT SYSTEM Cardiovascular 11/27/2018 INCRAFT US Post-Approval Study 03/26/2019 Study Pending
Long Term Follow-up Study Progress Adequate
P180050 CVRx, INC. BAROSTIM NEO® System Cardiovascular 08/16/2019 Extended Phase BeAT-HF PAS 08/16/2019 Progress Adequate
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Duraloc Long Term 05/03/2005 Revised/Replaced Study
P070026 DEPUY ORTHOPAEDICS, INC. CERAMAX CERAMIC HIP SYSTEM Orthopedic 12/23/2010 Ceramax PAS 12/23/2010 Progress Adequate
P070026
S004 		DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 Short-Mid-Term F/u of New COC36 patients 04/02/2013 Progress Inadequate
P120005
S041 		DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 12/20/2016 Dexcom G5 Mobile Cont Glucose Monitoring Sys -PAS 12/20/2016 Progress Adequate
P110014 Dilon Medical Technologies, Ltd. DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery		 12/27/2012 MarginProbe System US PAS 12/27/2012 Progress Adequate
P160036 DT MedTech LLC Hintermann Series H3 Total Ankle Replacement System Orthopedic 06/04/2019 Hinternmann Series H3 TAR Long Term Study 11/29/2019 Progress Adequate
Hintermann Series H3 TAR Performance Study 11/29/2019 Progress Adequate
P200015 Edwards Lifesciences, LLC Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System Cardiovascular 08/31/2020 SAPIEN 3 Pulmonic Long Term F/u Study 08/06/2020 Study Pending
SAPIEN 3 Pulmonic New Enrollment Study 08/07/2020 Study Pending
P860057
S029 		EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term 12/05/2008 Progress Adequate
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 Comprehensive/Linked-Registry Based Surv 06/16/2014 Progress Adequate
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 Continued f/u of premarket cohort 06/17/2015 Progress Adequate
Comprehensive/Linked-Registry Progress Adequate
P130009
S034 		EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 Continued f/u of the premarket cohort 10/09/2015 Progress Adequate
Comprehensive Linked Registry-Based Surv Progress Adequate
P130009
S037 		EDWARDS LIFESCIENCES, LLC. SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 02/29/2016 COMPASSION Cohort Progress Adequate
New Enrollment SAPIEN XT Pulmonic PAS 09/20/2016 Progress Inadequate
P150048 EDWARDS LIFESCIENCES, LLC. EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) Cardiovascular 06/29/2017 PAS Aortic Continued Follow-up 07/29/2017 Progress Adequate
Model 11500A Prospective PAS 01/08/2018 Progress Adequate
P140031
S010 		EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort 07/23/2018 Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P130009
S057 		EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort 11/04/2019 Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P140031
S028 		EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/05/2017 SAPIEN 3 Mitral Valve-in-Valve Comp Surv 11/20/2017 Progress Adequate
SAPIEN 3 Aortic Valve-in-Valve Comp Surv 11/20/2017 Progress Adequate
P150048
S012 		EDWARDS LIFESCIENCES, LLC. Edwards Pericardial Mitral Bioprosthesis, Model 11000M Cardiovascular 08/09/2018 Mitral Model 11000M, Cont f/u Post-Approval Study 11/05/2018 Progress Adequate
P140031
S074 		EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Cardiovascular 12/27/2018 SAPIEN 3 Ultra Novel Surveillance 12/27/2018 Progress Adequate
P140031
S085 		EDWARDS LIFESCIENCES, LLC. SAPIEN 3 Ultra transcatheter heart valve Cardiovascular 08/16/2019 Cont f/u of SAPIEN 3 Low Risk cohort PAS Study Pending
SAPIEN 3 Registry-Based Cont Access & Low Risk RWU Study Pending
P120006 Endologix, LLC OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 Long Term Follow-up Study 10/05/2012 Progress Adequate
P120006
S031 		Endologix, LLC Alto Abdominal Stent Graft System Cardiovascular 03/13/2020 Alto US and OUS Post-Approval Study 10/09/2020 Study Pending
Case Selection and Sizing Study 06/16/2020 Progress Adequate
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 New Enrollment 03/17/2010 Revised/Replaced Study
Esteem New Enrollment 2 04/16/2010 Progress Inadequate
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 Epi proColon PAS 10/18/2016 Progress Adequate
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 Cologuard PAS 02/02/2015 Progress Inadequate
P130017
S029 		Exact Sciences Corporation Cologuard Stool DNA-Based Colorectal Cancer Screening Test Pathology 09/20/2019 A Post-Marketing Real World Study 09/20/2019 Study Pending
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Long Term 07/05/2007 Revised/Replaced Study
Novation PAS 07/05/2007 Progress Inadequate
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 Prometra Programmable Pump system 05/03/2012 Progress Adequate
Extended Use Stability Study 05/04/2012 Progress Adequate
Leachables Study 05/04/2012 Progress Adequate
P170019
S017 		Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 10/23/2020 Post-Approval Study Protocol Pending
P200006 Foundation Medicine, Inc. FoundationOne Liquid CDx (F1 Liquid CDx) Molecular Genetics 10/26/2020 ARIEL2 PAS Protocol Pending
P170043 Glaukos Corporation iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) Ophthalmic 06/21/2018 Extended f/u Premarket Cohort 04/16/2019 Progress Inadequate
New Enrollment PAS 04/16/2019 Progress Inadequate
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 New Enrollment Study 06/25/2012 Progress Adequate
Registry Study 06/25/2012 Revised/Replaced Study
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Enhanced Surveillance 09/28/2012 Progress Adequate
P180007 Gyrus ACMI, Inc. Spiration® Valve System Anesthesiology 12/03/2018 EMPROVE Extension Study 03/01/2019 Progress Adequate
SVS Post-Market Registry Study 05/21/2019 Study Pending
H190001 HDL Therapeutics, Inc. Plasma Delipidation System (PDS-2™ System) Gastroenterology/
Urology		 12/01/2020 HALO-FHII PAS Protocol Pending
HF PAS Protocol Pending
P010013
S041 		HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology		 02/01/2013 NovaSure PAS 02/01/2013 Progress Inadequate
P170039 HumanOptics AG CustomFlex Artificial Iris Ophthalmic 05/30/2018 PAS, Adult and Pediatric 09/23/2019 Progress Adequate
Pediatric New Enrollment 10/03/2019 Progress Adequate
P120011 IDEALIMPLANT IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT General &
Plastic Surgery		 11/14/2014 Post-Approval PMA Cohort Study (PACS) 11/14/2014 Progress Adequate
P180036 Impulse Dynamics (USA), Inc. OPTIMIZER Smart System Cardiovascular 03/21/2019 OPTIMIZER System PAS Progress Adequate
P110039 InSightec EXABLATE General &
Plastic Surgery		 10/18/2012 New Enrollment Study 10/18/2012 Progress Adequate
P150038 InSightec EXABLATE Neurology 07/11/2016 Long Term PAS 09/29/2016 Progress Adequate
P150038
S006 		InSightec ExAblate Neurology 12/16/2018 PAS Registry Study for ExAblate 4000 11/06/2020 Study Pending
P040003
S015 		INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology		 08/31/2015 Post ExAblate Pregnancy Outcomes Registry 08/31/2015 Progress Inadequate
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 New Enrollment Study 04/30/2014 Progress Adequate
P130008
S039 		INSPIRE MEDICAL SYSTEMS Inspire Upper Airway Stimulation Anesthesiology 04/14/2020 Inspire Pediatric Post-Approval Registry 06/12/2020 Study Pending
P000057 INTEGRA LIFESCIENCES CORPORATION ASCENSION MCP Orthopedic 11/19/2001 Ascension MCPT 11/19/2001 Progress Adequate
P890055
S026 		Intera Oncology CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 Leachables Study 12/17/2010 Progress Adequate
Drug Stability Study 12/17/2010 Progress Adequate
P160050 INTRINSIC THERAPEUTICS BARRICAID ANULAR CLOSURE DEVICE (ACD) Orthopedic 02/08/2019 Extended F/U-Barricaid ACD Premarket Cohort 05/07/2019 Progress Adequate
Histological and Retrieval Analysis PAS 05/07/2019 Progress Adequate
P170034 Ivantis, Inc. HYDRUS MICROSTENT Ophthalmic 08/10/2018 Continuation of Premarket Cohort PAS 11/18/2015 Progress Adequate
Modified Hydrus New Enrollment PAS 10/08/2019 Progress Adequate
P980040
S065 		Johnson & Johnson Surgical Vision, Inc. TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS Ophthalmic 07/15/2016 TECNIS Symfony Toric New Enrollment Study 07/10/2018 Progress Adequate
H130001 KANEKA PHARMA AMERICA LLC KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN Gastroenterology/
Urology		 03/05/2015 New Enrollment Study 08/24/2015 Progress Inadequate
H120005 KANEKA PHARMA AMERICA LLC LIPOSORBER LA-15 SYSTEM Gastroenterology/
Urology		 10/10/2013 New Enroll. PAS for Liposorber LA-15 Sys 10/10/2013 Progress Adequate
H170002 Kaneka Pharma America LLC LIPOSORBER LA-15 System Gastroenterology/
Urology		 03/20/2018 New Enroll PAS LIPOSORBER LA-15 Adults 03/04/2019 Progress Adequate
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 New Enrollment PAS Registry 02/26/2018 Progress Inadequate
P000025
S104 		MED-EL CORP. MED-EL Cochlear Implant System Ear Nose & Throat 07/19/2019 MED-EL New Enrollment SSD/AHL Study 10/15/2019 Progress Adequate
P110004
S001 		MEDINOL LTD. NIRXCELL COCR CORONARY STENT ON RX SYSTEM Cardiovascular 12/19/2013 NIRTRAKS PAS 05/14/2015 Progress Adequate
P170008 Medinol, Ltd. EluNIR™ Ridaforolimus Eluting Coronary Stent System Cardiovascular 11/28/2017 Cont f/u of BIONICS Clinical Study 11/28/2017 Progress Adequate
P100047 Medtronic HEARTWARE VENTRICULAR ASSIST SYSTEM Cardiovascular 11/20/2012 Newly Enrolled (HW-PAS-01) 11/20/2012 Progress Inadequate
Training Program (HeartWare-PAS-02) 11/20/2012 Progress Adequate
Continued Follow-Up (HW-PAS-03) 02/14/2014 Progress Adequate
P100047
S090 		Medtronic HeartWare™ HVAD™ System Cardiovascular 09/27/2017 ENDURANCE PAS 07/26/2018 Progress Inadequate
Cont F/u of HW004-A ENDURANCE 03/15/2018 Progress Adequate
P010031
S232 		MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT Cardiovascular 04/04/2012 REVERSE NCDR ICD Registry Study 04/04/2012 Progress Adequate
REVERSE Product Surveillance Registry 04/04/2012 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 PCT Change Study 04/01/2016 Progress Adequate
P010031
S563 		MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT Claria MRI Quad CRT-D SureScan, Amplia MRI Quad CRT-D, Implantable Cardioverter Defibrillators with Cardiac Resynchronization. Cardiovascular 03/24/2017 MPP PAS Progress Adequate
P010031
S674 		MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION Cardiovascular 04/23/2020 iATP PAS Progress Adequate
P980016
S713 		MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS Cardiovascular 04/23/2020 iATP PAS Progress Adequate
P130021 MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 Contined f/u of IDE pivotal cohort 01/17/2014 Revised/Replaced Study
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 Continued f/u of the premarket cohorts 06/12/2014 Progress Adequate
Comprehensive/Linked-Registry Based Surv 06/12/2014 Progress Adequate
P130021
S010 		MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 03/30/2015 Continued f/u of the premarket cohort Progress Adequate
Comprehensive/Linked-Registry Progress Adequate
P130021
S014 		MEDTRONIC COREVALVE LLC COREVALVE (TM) EVOLUT(TM) R SYSTEM Cardiovascular 06/22/2015 Continued f/u of premarket cohort Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P130021
S016 		MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS Cardiovascular 11/10/2015 Comprehensive/Linked-Registry Based Surv 11/02/2015 Progress Adequate
Continued f/u of premarket cohort Progress Adequate
P130021
S025 		MEDTRONIC COREVALVE LLC Medtronic CoreValve Evolut R XL system Cardiovascular 10/26/2016 Continued f/u of premarket cohort Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P130021
S029 		MEDTRONIC COREVALVE LLC Medtronic CoreValve Evolut PRO System Cardiovascular 03/20/2017 Cont f/u of CoreValve Evolut PRO System 03/20/2017 Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P130021
S033 		MEDTRONIC COREVALVE LLC CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System Cardiovascular 07/10/2017 Intermediate Risk Surveillance 04/09/2018 Progress Adequate
Cont f/u Intermediate Risk Cohort Progress Adequate
P130021
S058 		MEDTRONIC COREVALVE LLC Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System Cardiovascular 08/16/2019 Cont fu of Evolt R and PRO Sys Low Risk cohort PAS 03/20/2020 Progress Adequate
Evolut R and PRO Sys Registry-Based Low Risk RWU 03/20/2020 Study Pending
P100010
S098 		Medtronic CryoCath LP Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters Cardiovascular 06/23/2020 Cryo AF Global Registry Protocol Pending
P080006
S004 		MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD Cardiovascular 03/31/2011 Attain Ability Straight Model 4396 03/31/2011 Progress Adequate
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 PAS of TS Feat. w Sensor-Augment Pump Sys 09/26/2013 Revised/Replaced Study
P080006
S068 		MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD Cardiovascular 08/01/2014 Post-Approval Study Registry 08/01/2014 Progress Adequate
P080006
S073 		MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS Cardiovascular 12/10/2014 Post-Approval Study Registry 12/10/2014 Progress Adequate
P960009
S219 		MEDTRONIC Inc. MEDTRONIC DBS THERAPY FOR EPILEPSY Neurology 04/27/2018 DBS for Epilepsy New Enrollment PAS 10/12/2018 Progress Adequate
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 Micra Transcatheter Pacing System PAS 03/08/2016 Progress Adequate
P980035
S442 		MEDTRONIC Inc. ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE Cardiovascular 04/28/2016 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 PCT Change Study 04/01/2016 Progress Adequate
P140010
S015 		MEDTRONIC Inc. IN PACT(TM) ADMIRAL(TM) PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 09/07/2016 Surveillance Post Market Registry 12/06/2016 Progress Adequate
P080006
S129 		MEDTRONIC Inc. Attain Stability Quad MRI SureScan Lead Cardiovascular 04/10/2019 Attain Stability Quad PAS 04/10/2019 Progress Adequate
P150033
S061 		MEDTRONIC Inc. Micra Transcatheter Pacing System, Micra AV Application Software Cardiovascular 01/15/2020 Micra AV Post Approval Study 01/15/2020 Progress Adequate
P160017 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 09/28/2016 MiniMed 670G Post Approval Study 12/22/2016 Progress Adequate
P160017
S031 		MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 06/21/2018 Post-Approval Study 06/21/2018 Progress Adequate
P970004
S022 		MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology		 09/24/2002 Urgency Frequency (UF 1635) 09/24/2002 Revised/Replaced Study
Urinary Urge Incontinence (UUI) 09/24/2002 Revised/Replaced Study
P090029 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 07/24/2014 Enhanced Surveillance Study 04/06/2015 Revised/Replaced Study
Device Failure 03/11/2016 Revised/Replaced Study
P090029
S003 		Medtronic Sofamor Danek USA, Inc. PRESTIGE LP(TM) CERVICAL DISC Orthopedic 07/07/2016 PRESTIGE LP 2-Level Metal Concentrations 02/13/2018 Progress Adequate
P090029
S006 		Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 12/15/2016 Device Failure and Complaint Analysis 12/15/2016 Progress Adequate
P100040
S012 		Medtronic Vascular VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 Comprehensive/Linked-Registry Based Surv. 06/23/2014 Progress Adequate
P160043 MEDTRONIC VASCULAR RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 04/28/2017 RESOLUTE ONYX PAS Progress Adequate
P100021
S063 		Medtronic Vascular Endurant II/IIs Stent Graft System Cardiovascular 09/29/2017 Cont f/u ANCHOR Reg Short Neck Cohort 09/29/2017 Progress Inadequate
P160043
S001 		MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 11/16/2017 RESOLUTE ONYX PAS Progress Adequate
P160043
S012 		MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 12/14/2018 RESOLUTE ONYX CTO Post-approval study 03/08/2019 Progress Adequate
P110013
S088 		Medtronic Vascular Resolute Integrity Zotarolimus-Eluting Coronary Stent System Cardiovascular 12/14/2018 RESOLUTE ONYX CTO Post-approval study 03/08/2019 Progress Adequate
P100040
S036 		Medtronic Vascular Valiant Navion Thoracic Stent Graft System Cardiovascular 10/19/2018 Continued f/u Valiant EVO Study Progress Adequate
P190008 Medtronic Vascular Inc. IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Cardiovascular 11/21/2019 IN.PACT AV Access IDE Cohort PAS 11/14/2019 Study Pending
New Enrollment IN.PACT AV Access PAS 04/10/2020 Progress Adequate
P200026 Medtronic Vascular, Inc. Abre Venous Self-expanding Stent System Cardiovascular 10/21/2020 ABRE Continued Follow-up Study 09/24/2018 Study Pending
P090013
S205 		Medtronic, Inc CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI Cardiovascular 04/28/2016 PCT Change Study 04/01/2016 Progress Adequate
P140032 Medtronic, Inc. Implantable System for Remodulin General Hospital 12/22/2017 Post-Approval Study 07/27/2018 Progress Adequate
P890003
S338 		Medtronic, Inc. CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS MONITOR Cardiovascular 02/01/2016 MR conditional Tachy Therapy Systems Stud Progress Adequate
P930039
S142 		Medtronic, Inc. CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 Cardiovascular 04/28/2016 PCT Change Study 04/01/2016 Progress Adequate
P890003
S354 		Medtronic, Inc. CARELINK MONITOR MODELS 2490C AND 2491 DDMA, CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MYCARELINK PATIENT MONITOR MODEL 24950. Cardiovascular 10/12/2016 MR conditional Tachy Therapy Systems Progress Adequate
P890003
S372 		Medtronic, Inc. SYNERGYST II PULSE GENERATOR Cardiovascular 09/01/2017 Heart Failure Risk Status (HFRS) PAS Study Pending
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery		 11/17/2006 Large PAS 11/17/2006 Revised/Replaced Study
Re-Op Phase 01/16/2015 Progress Inadequate
MemoryGel and Shape Glow Study 10/01/2014 Progress Inadequate
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery		 06/14/2013 MemoryGel and Shape Glow Study 06/14/2013 Progress Inadequate
P050052
S049 		MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery		 06/04/2015 Radiesse New Enrollment Study 11/23/2015 Progress Adequate
P170013 MicroVention, Inc. Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Neurology 05/30/2018 PAS-Post-Market Surveillance Study/LongTerm Safety 11/17/2020 Protocol Overdue
P170032 MicroVention, Inc. Woven EndoBridge (WEB) Aneurysm Embolization System Neurology 12/31/2018 PAS1 - PostMarket Surveillance-Long Term Safety 12/31/2018 Protocol Overdue
PAS2 - WEB-IT Study Progress Adequate
P010047 NEOMEND, INC. PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 01/14/2010 Long Term Safety 01/14/2010 Progress Adequate
P010047
S010 		NEOMEND, INC. NEOMEND PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 12/21/2011 NeoMend ProGel Pleural Air Leak Sealant 12/21/2011 Progress Adequate
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 New Enrollment - All Comers 11/14/2013 Progress Adequate
New Enrollment -Performance & Programming 11/14/2013 Progress Adequate
Autopsy Study 11/14/2013 Progress Adequate
P100034 Novocure GmbH NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 New Enrollment Study for NovoTTF-100A 04/08/2011 Revised/Replaced Study
Registry Study for Optune System 02/09/2016 Progress Adequate
P150028 NUMED, INC. CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) Cardiovascular 03/25/2016 Continued f/u of Premarket Cohorts 03/25/2016 Progress Adequate
Cont f/u of premarket cohorts w/stent fra 03/25/2016 Progress Adequate
P150028
S001 		NUMED, INC. Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) Cardiovascular 10/24/2017 PARCS continued f/u survey 10/24/2017 Progress Adequate
P160001 OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM Gastroenterology/
Urology		 09/08/2016 Obalon Balloon System PAS 07/19/2017 Progress Adequate
P160001
S003 		OBALON THERAPEUTICS, INC. OBALON BALLOON SYSTEM Gastroenterology/
Urology		 04/25/2017 Obalon Balloon System PAS 07/19/2017 Progress Adequate
P130004 OCULAR THERAPEUTIX, INC. RESURE SEALANT Ophthalmic 01/08/2014 Device Exposure Registry Study 01/08/2014 Revised/Replaced Study
Retrospective Analysis Study for Endophthalmitis 05/05/2020 Study Pending
P000037
S030 		On-X Life Technologies, Inc. ON-X PROSTHETIC HEART VALVE Cardiovascular 04/01/2015 Newly Enrolled On-X PAS 06/19/2015 Progress Adequate
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 Nit-Occlud PDA PAS 08/16/2013 Progress Adequate
P180034 Philips Image Guided Therapy Corporation Tack Endovascular System (6F) Cardiovascular 04/11/2019 TOBA II Continued f/u Study Progress Adequate
P190027 Philips Image Guided Therapy Corporation (formerly Intact) Tack Endovascular System (4F, 1.5-4.5mm) Cardiovascular 04/10/2020 TOBA II BTK Continued Follow-up Study 04/10/2020 Progress Adequate
P150039 Poseidon Medical Inc. TRYTON SIDE BRANCH STENT Cardiovascular 02/21/2017 TRYTON Side Branch New Enrollment Study 07/13/2017 Progress Adequate
P180002 Pulmonx Corporation Zephyr Endobronchial Valve System Anesthesiology 06/29/2018 LIBERATE Extension Study 09/25/2018 Progress Adequate
ZEVR-Zephyr Valve Registry 05/03/2019 Progress Adequate
P180002
S005 		Pulmonx Corporation Zephyr Endobronchial Valve (EBV) System Anesthesiology 07/30/2019 ZEVR-Zephyr Valve Registry 10/02/2019 Progress Adequate
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology		 11/18/2011 Deep Hyperthermia and Radiation 11/18/2011 Revised/Replaced Study
Enhanced Surveillance Study 11/18/2011 Progress Adequate
P030050
S002 		Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery		 07/28/2009 Clinical PAS 07/28/2009 Progress Adequate
P160052 QIAGEN Inc PartoSure test Toxicology 04/11/2018 Partosure PAS 10/11/2019 Progress Adequate
P000008 ReShape Lifesciences, Inc. LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology		 06/05/2001 Lap-Band Long Term 06/05/2001 Revised/Replaced Study
P130019 ReShape Lifesciences, Inc. MAESTRO RECHARGEABLE SYSTEM Gastroenterology/
Urology		 01/14/2015 Extended F/u of Premarket Cohort 06/02/2015 Progress Adequate
P110008 RTI Surgical, Inc COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 Coflex Actual Practice PAS 10/17/2012 Revised/Replaced Study
Coflex Actual Practice PAS USA 08/05/2015 Progress Inadequate
P150034 RVO 2.0, Inc. (d.b.a. Optics Medical) Raindrop Near Vision Inlay Ophthalmic 06/29/2016 Post-Approval Study 12/27/2016 Progress Adequate
P160055 RxSight, Inc. LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) Ophthalmic 11/22/2017 LAL/LDD Postmarket RCT 03/04/2019 Progress Adequate
P050034 Samsara Vision Inc. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 IMT PAS 01 New Enrollment Study 07/01/2010 Progress Adequate
P160048 Senseonics, Incorporated EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 06/21/2018 Post-Approval Study 09/18/2018 Progress Adequate
P160048
S006 		Senseonics, Incorporated Eversense Continuous Glucose Monitoring System Clinical Chemistry 06/06/2019 Eversense CGM Non-Adjunctive PAS 11/25/2019 Progress Adequate
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery		 03/09/2012 US Post-Approval Study (US-PAS) 03/09/2012 Progress Inadequate
Post-Approval PMA Cohorts Study (PACS) 03/09/2012 Progress Adequate
P200022 Simplify Medical, Inc. Simplify® Cervical Artificial Disc Orthopedic 09/18/2020 Extended Follow-up of IDE Subjects 11/05/2020 Study Pending
P150030 Smith & Nephew, Inc. R3 DELTA CERAMIC HIP SYSTEM Orthopedic 10/17/2016 Long-Term F/u of EU patients PAS 10/17/2016 Progress Adequate
Short to Mid-Term f/u of New US Patients 10/17/2016 Progress Adequate
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 US Study 05/09/2006 Progress Adequate
P170036 Spinal Kinetics LLC M6-C Artificial Cervical Disc Orthopedic 02/06/2019 M6-C Artificial Cervical Disc-Extended Follow-up 08/02/2019 Progress Adequate
P100045 St. Jude Medical CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Cardiovascular 05/28/2014 Newly Enrolled Champion 05/28/2014 Progress Adequate
Champion Substudy 05/28/2014 Progress Adequate
P130026 St. Jude Medical TACTICATH QUARTZ SET Cardiovascular 10/24/2014 TactiCath Quartz PAS 08/20/2014 Progress Adequate
P950022
S085 		St. Jude Medical, Inc. OPTISURE Cardiovascular 02/21/2014 OptiSure Lead Post Approval Study 02/21/2014 Progress Adequate
Externalization and Abrasion Sub-Study 02/21/2014 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 SJM Brady MRI PAS 01/31/2017 Progress Adequate
P810002
S101 		St. Jude Medical, Inc. SJM Masters Series Mechanical Heart Valve, 15mm HP Cardiovascular 03/06/2018 Cont f/u of the premarket HALO Cohort 03/06/2018 Progress Adequate
HALO PAS 12/07/2018 Progress Adequate
P030016
S001 		STAAR Surgical Company Visian Toric ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 09/13/2018 Visian Toric ICL New Enrollment PAS 03/07/2019 Progress Adequate
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 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 Long Term Study 05/27/2009 Progress Adequate
Actual Conditions of Use Study (STAR 2) 05/27/2009 Progress Inadequate
P170024 Stryker Neurovascular Surpass Streamline Flow Diverter Neurology 07/13/2018 SCENT Post-Approval Study Progress Adequate
P180031 Stryker Neurovascular Neuroform Atlas® Stent System Neurology 05/16/2019 ATLAS Study 01/18/2020 Progress Adequate
P030011
S011 		SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 Companion 2 Driver System PAS Protocol Pending
Enhanced Surveillance 05/16/2012 Revised/Replaced Study
P160049 The Spectranetics Corp. STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON Cardiovascular 07/26/2017 ILLUMINATE Continued Follow-Up Study 07/26/2017 Progress Adequate
P170027 TherOx, Inc. TherOx Downstream System Cardiovascular 04/02/2019 New Enrollment Study 11/20/2020 Study Pending
P160054
S008 		Thoratec Corporation HeartMate 3 Left Ventricular Assist System Cardiovascular 10/18/2018 Continued f/u of Premarket Pivotal Cohort 01/18/2019 Progress Adequate
Continued f/u of Continued Access Cohort 01/18/2019 Progress Adequate
P870072
S037 		THORATEC LABORATORIES CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 Thoratec TLC-ii portable 11/14/2007 Progress Adequate
P100049 TORAX MEDICAL LINX REFLUX MANAGEMENT SYSTEM Gastroenterology/
Urology		 03/22/2012 Enrollment Study 03/22/2012 Progress Adequate
P160013 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology		 03/22/2018 TOP PAS Registry 06/18/2018 Progress Adequate
INSPIRE Continuation PAS Progress Inadequate
P160013
S002 		TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology		 05/31/2019 OCS-LUN-PAS 05/31/2019 Progress Adequate
EXPAND Continuation PAS 05/31/2019 Progress Adequate
P130018 UROMEDICA INC PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN Gastroenterology/
Urology		 11/24/2015 ProAct Post-Approval Study 11/02/2016 Progress Inadequate
P040050 UROPLASTY, LLC MACROPLASTIQUE IMPLANTS Gastroenterology/
Urology		 10/30/2006 5 year registry - ROSE 10/30/2006 Progress Adequate
P040043
S051 		W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 Comprehensive/Linked-Registry Based Surv 06/23/2014 Progress Inadequate
P040037
S060 		W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE Cardiovascular 09/19/2014 New Enrollment Study 04/03/2015 Progress Adequate
P020004
S123 		W.L. GORE & ASSOCIATES,INC GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS Cardiovascular 02/29/2016 Post-Approval Study 02/29/2016 Progress Adequate
P050006
S060 		W.L. GORE & ASSOCIATES,INC GORE CARDIOFORM Septal Occluder Cardiovascular 03/30/2018 Continued f/u of IDE Cohort Progress Adequate
GORE CARDIOFORM New Enrollment PAS 12/07/2018 Progress Adequate
P050006
S071 		W.L. GORE & ASSOCIATES,INC GORE Cardioform ASD Occluder Cardiovascular 05/28/2019 Continued F/u of the ASSURED Study Progress Adequate
P070016 WILLIAM COOK EUROPE APS ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM Cardiovascular 05/21/2008 Longterm PAS 11/26/2008 Progress Adequate
P180001 WILLIAM COOK EUROPE APS Zenith Dissection Endovascular System Cardiovascular 12/31/2018 Continued f/u of pivotal study Progress Adequate
SVS VQI Postmarket Surveillance Study 10/31/2019 Progress Adequate
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology		 05/12/2017 Flourish Post-Approval Study 04/27/2018 Revised/Replaced Study
H150003
S005 		WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Device Gastroenterology/
Urology		 10/02/2020 Flourish Real-World Evidence PAS 10/02/2020 Study Pending
H120003 XVIVO PERFUSION XPS WITH STEEN SOLUTION PERFUSATE Gastroenterology/
Urology		 08/12/2014 Long-Term Study 04/10/2015 Progress Adequate
P180014 XVIVO Perfusion, Inc. XPS™ with Steen Solution™ Perfusate Gastroenterology/
Urology		 04/26/2019 NOVEL/NOVEL Ext Cont Long Term PAS 10/29/2019 Progress Adequate
Long Term Eval PAS of XPS System 10/29/2019 Progress Adequate
P110002 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Enhanced Surveillance System 05/16/2014 Progress Adequate
Retrieval Analysis 07/15/2014 Progress Adequate
P110009 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Enhanced Surveillance System 08/23/2013 Progress Adequate
Retrieval Analysis 08/23/2013 Progress Adequate
H190005 Zimmer Biomet Spine, Inc. The Tether™ - Vertebral Body Tethering System Orthopedic 08/16/2019 The Tether Vertebral Tethering System Registry PAS 01/13/2020 Study Pending
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Long term 06/28/2006 Revised/Replaced Study
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 Long Term Study 11/06/2008 Progress Inadequate
P160022 ZOLL MEDICAL CORPORATION X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ Battery Pack, SurePower II™ Battery Pack, AED Pro® Non-Rechargeable Lithium Battery Pack, AED 3™ Battery Pack, SurePower™ Charger, and SurePower™ Single Bay Charger Cardiovascular 12/27/2017 Reconfirmation Analysis Mode Algorithm PAS Progress Adequate
P160015
S001 		ZOLL MEDICAL CORPORATION AED 3 defibrillator Cardiovascular 02/28/2020 AED 3 and Pad Placement PAS 06/05/2020 Study Pending


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