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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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Approved
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Study
Name
Date Original
Protocol
Accepted
Study Status
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
P980023
S057
BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P980016
S713
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DDPC3D4 and DDPC3Dl); Cobalt XT VR MRI SureScan (DVPA2D4 and DVPA2D1); Cobalt VR MRI SureScan (DVPB3D4 and DVPB3Dl); and Crome VR MRI SureScan (DVPC3D4 and DVPC3Dl) Implantable Cardioverter Defibrillators Cardiovascular 04/23/2020 iATP PAS 04/23/2020 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
P970051
S205
Cochlear Americas Nucleus 24 Cochlear Implant System Ear Nose & Throat 01/10/2022 Cochlear New Enrollment SSD/UHL Study 03/11/2022 Study Pending
P960040
S385
BOSTON SCIENTIFIC NG4 Family of Pulse Generators ICDS. Cardiovascular 05/02/2017 MANAGE-HF 07/25/2017 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 Inadequate
P930016
S053
AMO Manufacturing USA, LLC iDESIGNRefractive Studio, STAR Excimer Laser System Ophthalmic 06/15/2018 Post-Approval Study 01/29/2019 Progress Inadequate
P910073
S145
BOSTON SCIENTIFIC Reliance 4- Front Lead Family and Suture Sleeve Accessory Cardiovascular 05/04/2018 MOUNTAIN PAS 05/04/2018 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
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 09/01/2017 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
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
P810002
S101
Abbott Medical 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
P220003 Edwards LifeSciences LLC PASCAL Precision Transcatheter Valve Repair System Cardiovascular 09/14/2022 Continued Follow-up of the CLASP III Trial Cohort 09/14/2022 Study Pending
Registry-Based Real-World Use Surveillance 09/14/2022 Study Pending
P210034 CartiHeal Ltd. Agili-C Orthopedic 03/29/2022 Extended Follow-up of the Premarket Cohort 03/29/2022 Study Pending
P210032 W. L. Gore & Associates, Inc. GORE TAG Thoracic Branch Endoprosthesis (TBE Device) Cardiovascular 05/13/2022 Continued Follow-up of the IDE Study 05/13/2022 Study Pending
Post-Market Surveillance Study 07/08/2022 Study Pending
P210020 Urotronic, Inc. Optilume Urethral Drug Coated Balloon Gastroenterology/
Urology
12/03/2021 ROBUST-LT Post-Approval Study (PR1277) 01/19/2022 Study Pending
URINATE PAS (PR1276) 02/03/2022 Progress Adequate
STREAM PAS (PR1275) 01/27/2022 Progress Adequate
P210014 Svelte Medical Systems, Inc. SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System Cardiovascular 12/13/2021 Cont f/u of OPTIMIZE Clinical Study 12/13/2021 Study Pending
P210006 Vascutek Ltd. Thoraflex™ Hybrid Cardiovascular 04/19/2022 EXTEND Post-Approval Study 08/08/2022 Study Pending
P210005 AcuFocus, Inc. IC-8 Apthera Intraocular Lens (IOL) Ophthalmic 07/22/2022 Continuation Study - SAIL-101-PAS 09/20/2022 Study Pending
New Enrollment Study-IC-8 Apthera IOL 09/20/2022 Study Pending
P210001
S001
Ventana Medical Systems Inc (Roche Tissue Diagnostics) VENTANA MMR RxDx Panel Pathology 03/21/2022 KEYTRUDA PAS 05/20/2022 Study Pending
P200049 Abbott Medical Amplatzer™ Amulet™ Left Atrial Appendage Occluder Cardiovascular 08/14/2021 Continued Follow-up of the Amulet IDE Cohort 08/14/2021 Progress Adequate
Amulet Real-World Use Surveillance 12/09/2021 Study Pending
P200046 Medtronic, Inc. Harmony™ TPV System Cardiovascular 03/26/2021 Continued Follow-up of the Harmony TPV IDE Cohort 03/26/2021 Progress Adequate
Harmony TPV New Enrollment Study 03/26/2021 Progress Adequate
P200045 Bolton Medical, Inc. RelayPro Thoracic Stent-Graft System Cardiovascular 08/05/2021 Continued f/u of the IDE Study Subjects 08/05/2021 Study Pending
RelayPro Post-Approval Surveillance Study 11/16/2021 Progress Adequate
P200039 Shockwave Medical, Inc. Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Cardiovascular 02/12/2021 New Enrollment PAS Registry 06/04/2021 Progress Adequate
DISRUPT CAD III Cont f/u Study 04/09/2021 Progress Adequate
P200037 Kestra Medical Technologies, Inc. ASSURE Wearable Cardioverter Defibrillator (WCD) System Cardiovascular 07/27/2021 ACE-PAS 07/27/2021 Progress Adequate
P200036 Valencia Technologies Corporation eCoin Peripheral Neurostimulator Gastroenterology/
Urology
03/01/2022 Continued Follow-Up of G170301 Clinical Study 03/01/2022 Study Pending
Post-Approval Study of eCoin-RECIPE 03/30/2022 Study Pending
P200035 OrganOx Limited OrganOx metra System Gastroenterology/
Urology
12/09/2021 WP01 Long-Term Follow-up PAS 12/09/2021 Study Pending
New Enrollment PAS 12/09/2021 Study Pending
P200031 TransMedics, Inc. Organ Care System (OCS™) Liver Gastroenterology/
Urology
09/28/2021 PROTECT CAP Continuation PAS 09/28/2021 Progress Adequate
OLP New Enrollment PAS 09/28/2021 Progress Adequate
P200030 W. L. Gore and Associates, Inc. Gore Excluder Conformable AAA Endoprosthesis (CEXC) Cardiovascular 12/22/2020 Cont f/u of the IDE Study Subjects 12/22/2020 Progress Adequate
P200029 Boston Scientific Corporation TheraSphere Radiology 03/17/2021 The Patient Exposure Study 05/14/2021 Progress Adequate
P200028 Medtronic Inc. DiamondTemp Ablation System Cardiovascular 01/28/2021 DIAMOND AF PAS 11/02/2021 Study Pending
P200022 NuVasive, Inc. Simplify® Cervical Artificial Disc Orthopedic 09/18/2020 Extended Follow-up of IDE Subjects 11/05/2020 Progress Adequate
P200022
S003
NuVasive, Inc. Simplify Cervical Artificial Disc Orthopedic 04/01/2021 Extended f/u of the 2-Level Simplify 05/28/2021 Progress Adequate
P200021 Oticon Medical Neuro Cochlear Implant System Ear Nose & Throat 06/23/2021 New Enrollment Study 08/20/2021 Study Pending
P200020 Lenstec, Inc. SBL-3 Multifocal Intraocular Lens Ophthalmic 07/22/2022 Lenstec SBL-3 PAS 09/16/2022 Study Pending
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 Progress Adequate
SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION 04/16/2021 Progress Adequate
P200015
S011
Edwards Lifesciences, LLC Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent Cardiovascular 12/16/2021 Cont f/u of the Alterra IDE Cohort 12/16/2021 Study Pending
Alterra New Enrollment Study 12/16/2021 Study Pending
P200006 Foundation Medicine, Inc. FoundationOne Liquid CDx (F1 Liquid CDx) Pathology 10/26/2020 ARIEL2 PAS 02/03/2022 Study Pending
P200002 AtriCure, Inc. EPi-Sense Guided Coagulation System Cardiovascular 04/28/2021 CONVERGE Post-Approval Study 04/28/2021 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
P190023 Abbott Medical Portico Transcatheter Aortic Valve Implantation System Cardiovascular 09/17/2021 Registry-Based Real World use Surv of the Portico 11/12/2021 Progress Adequate
P190020 Biosensors International USA, Inc. BioFreedom Drug Coated Coronary Stent System Cardiovascular 04/14/2022 LEADERS FREE II (LFII) Clinical Study 04/14/2022 Study Pending
P190019 Boston Scientific Corporation Ranger™ Paclitaxel-Coated PTA Balloon Catheter Cardiovascular 10/30/2020 RANGER II SFA Cont F/u Study 12/16/2020 Progress Adequate
Range Long Balloon, Ranger China & COMPARE I f/u 12/16/2020 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 Progress Adequate
TREO Post Approval Study 07/31/2020 Progress Adequate
P190012 Spatz FGIA Inc. Spatz3 Adjustable Balloon System Gastroenterology/
Urology
10/15/2021 Spatz3 Post-Approval Study 10/15/2021 Progress Inadequate
P190009 Integrum AB OPRA Implant System Orthopedic 12/18/2020 Osseointegration Quality Registry PAS 02/12/2021 Progress Adequate
TFAOS PAS 02/12/2021 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 Progress Adequate
New Enrollment IN.PACT AV Access PAS 04/10/2020 Progress Adequate
P180051 TransMedics, Inc. Organ Care System (OCS) Heart System Cardiovascular 09/03/2021 OCS Heart EXPAND+CAP Continued f/u PAS 09/03/2021 Study Pending
OCS Heart Perfusion Post-Approval Registry 09/03/2021 Progress Adequate
P180051
S001
TransMedics, Inc. OCS Heart System Cardiovascular 04/27/2022 OCS-HEART-03-PAS 04/27/2022 Study Pending
OCSHEART-01-ClinPAS 04/27/2022 Study Pending
P180050 CVRx, INC. BAROSTIM NEO® System Cardiovascular 08/16/2019 Extended Phase BeAT-HF PAS 08/16/2019 Progress Adequate
P180036 Impulse Dynamics (USA), Inc. OPTIMIZER Smart System Cardiovascular 03/21/2019 OPTIMIZER System PAS 03/21/2019 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 07/26/2021 Progress Inadequate
MiSight 1 Day Safety PAS 07/12/2021 Progress Inadequate
P180031 Stryker Neurovascular Neuroform Atlas® Stent System Neurology 05/16/2019 ATLAS Study 05/16/2019 Progress Adequate
P180027
S002
MicroVention, Inc. Flow Re-Direction Endoluminal Device (FRED®) System Neurology 09/16/2021 FRED X PAS 04/26/2022 Study Pending
P180014 XVIVO Perfusion, Inc. XPS™ with Steen Solution™ Perfusate Gastroenterology/
Urology
04/26/2019 Long Term Eval PAS of XPS System 10/29/2019 Progress Adequate
NOVEL/NOVEL Ext Cont Long Term PAS 10/29/2019 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
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 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
P180001 WILLIAM COOK EUROPE APS Zenith Dissection Endovascular System Cardiovascular 12/31/2018 SVS VQI Postmarket Surveillance 12/31/2018 Progress Adequate
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 Adequate
P170042
S002
C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 03/01/2019 AVeNEW PAS 10/31/2019 Progress Adequate
P170039 HumanOptics AG CustomFlex Artificial Iris Ophthalmic 05/30/2018 PAS, Adult and Pediatric 09/23/2019 Progress Inadequate
Pediatric New Enrollment 10/03/2019 Progress Inadequate
P170038 Abbott CentriMag Circulatory Support System Cardiovascular 12/06/2019 CentriMag FTW PAS 05/22/2020 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
P170034 Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC HYDRUS MICROSTENT Ophthalmic 08/10/2018 Modified Hydrus New Enrollment PAS 10/08/2019 Progress Adequate
P170032 MicroVention, Inc. Woven EndoBridge (WEB) Aneurysm Embolization System Neurology 12/31/2018 PAS1 - PostMarket Surveillance-Long Term Safety 03/29/2021 Progress Inadequate
PAS2 - WEB-IT Study 12/31/2018 Progress Adequate
P170030 Biotronik, Inc ORSIRO Sirolimus Eluting Coronary Stent System Cardiovascular 02/22/2019 Bioflow-VII New Enrollment PAS 11/12/2019 Progress Adequate
P170027 TherOx, Inc. TherOx Downstream System Cardiovascular 04/02/2019 New Enrollment Study 11/20/2020 Progress Inadequate
P170019
S014
Foundation Medicine, Inc. FoundationOne CDx Pathology 06/07/2022 ROZYLTREK PAS Protocol Pending
P170019
S017
Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 10/23/2020 Post-Approval Study 05/06/2022 Progress Adequate
P170019
S029
Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 02/18/2022 KEYNOTE PAS 04/13/2022 Study Pending
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 Progress Adequate
P170011 Abiomed, Inc. Impella RP System Cardiovascular 09/20/2017 Impella RP-RWE Eval and Reporting 09/20/2017 Progress Adequate
P170011
S035
Abiomed, Inc. Impella RP System, Impella RP with SmartAssist System Cardiovascular 04/19/2022 Impella Real World Surveillance 08/18/2022 Study Pending
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 New Enrollment PAS Registry 02/26/2018 Progress Inadequate
P160055 RxSight, Inc. LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) Ophthalmic 11/22/2017 LAL/LDD Postmarket RCT 03/04/2019 Progress Inadequate
P160054
S008
Abbott Medical HeartMate 3 Left Ventricular Assist System Cardiovascular 10/18/2018 Continued f/u of Premarket Pivotal Cohort 01/18/2019 Progress Adequate
P160054
S031
Abbott Medical HeartMate 3 Left Ventricular Assist System (HM3 LVAS) Cardiovascular 12/17/2020 Heartmate 3 Real-World Pediatric Use Surveillance 12/17/2020 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 Inadequate
Histological and Retrieval Analysis PAS 05/07/2019 Progress Adequate
P160048 Senseonics, Incorporated EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 06/21/2018 Post-Approval Study 09/18/2018 Progress Inadequate
P160048
S006
Senseonics, Incorporated Eversense Continuous Glucose Monitoring System Clinical Chemistry 06/06/2019 Eversense CGM Non-Adjunctive PAS 11/25/2019 Progress Inadequate
P160045
S027
LIFE TECHNOLOGIES CORPORATION Oncomine™ Dx Target Test Pathology 12/01/2021 PAS Clinical Study 01/21/2022 Progress Adequate
P160043 MEDTRONIC VASCULAR RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 04/28/2017 RESOLUTE ONYX PAS Progress Adequate
P160043
S001
MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 11/16/2017 RESOLUTE ONYX PAS 11/16/2017 Progress Adequate
P160036 DT MedTech LLC Hintermann Series H3 Total Ankle Replacement System Orthopedic 06/04/2019 Hintermann Series H3 TAR Long Term Study 11/29/2019 Progress Adequate
Hintermann Series H3 TAR Performance Study 11/29/2019 Progress Adequate
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 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 12/27/2017 Progress Adequate
P160017 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 09/28/2016 MiniMed 670G Post Approval Study 12/22/2016 Progress Inadequate
P160017
S031
MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 06/21/2018 Post-Approval Study 06/21/2018 Progress Inadequate
P160015
S001
ZOLL MEDICAL CORPORATION AED 3 defibrillator Cardiovascular 02/28/2020 AED 3 and Pad Placement PAS 06/05/2020 Progress Adequate
P160013 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology
03/22/2018 TOP PAS Registry 06/18/2018 Progress Inadequate
P160013
S002
TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology
05/31/2019 OCS-LUNG-PAS 05/31/2019 Progress Inadequate
P150048 EDWARDS LIFESCIENCES, LLC. EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) Cardiovascular 06/29/2017 Model 11500A Prospective PAS 01/08/2018 Progress Adequate
PAS Aortic Continued Follow-up 07/29/2017 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
P150040
S003
Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser Ophthalmic 10/04/2018 VisuMax SMILE New Enrollment 07/25/2019 Progress Inadequate
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 Progress Inadequate
P150038
S014
InSightec Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Neurology 10/29/2021 ExAblate Neuro PAS 06/30/2022 Study Pending
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
P150035 Abbott Medical Aveir VR Leadless System Cardiovascular 03/31/2022 The Aveir VR RWE Study 03/31/2022 Study Pending
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 Micra Transcatheter Pacing System PAS 03/08/2016 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
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 Inadequate
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
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 PAS of HeartLight Endoscopic Ablation Sys 04/01/2016 Progress Adequate
P150026
S002
CARDIOFOCUS, INC. Heart Light Catheter with Excalibur Balloon Cardiovascular 05/02/2018 CF HeartLight PAS 05/02/2018 Progress Adequate
P150026
S008
CARDIOFOCUS, INC. HeartLight Endoscopic Ablation System Cardiovascular 05/08/2020 HeartLight X3 PAS 07/01/2020 Progress Adequate
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ABSORB IV Post-Approval Study Progress Adequate
P150009 ANGEL MEDICAL SYSTEMS INC. ANGELMED GUARDIAN SYSTEM Cardiovascular 04/09/2018 AngelMed Guardian PAS 08/14/2018 Study Pending
P150005
S014
Boston Scientific Corp. Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter Cardiovascular 12/21/2017 INTERRUPT (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
P150005
S049
Boston Scientific Corp. IntellaNav MiFi Open-Irrigated Ablation Catheter Cardiovascular 04/17/2020 DirectSense RF Sub-study 05/29/2020 Progress Adequate
P150004 Abbott Medical Axium Neurostimulator System Neurology 02/11/2016 F/U Axium Neurostimulator System (FANS) 05/26/2016 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
P150003
S054
BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System Cardiovascular 01/22/2021 Synergy Megatron PAS 03/19/2021 Progress Adequate
P150002 Cordis US Corporation INCRAFT(R) AAA STENT GRAFT SYSTEM Cardiovascular 11/27/2018 INCRAFT US Post-Approval Study 03/26/2019 Study Pending
Long Term INSPIRATION Study 11/27/2018 Progress Adequate
P140033 Abbott Medical 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
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 Comprehensive/Linked-Registry 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
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
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 08/16/2019 Progress Adequate
SAPIEN 3 Registry-Based Cont Access & Low Risk RWU 08/16/2019 Progress Adequate
P140031
S107
EDWARDS LIFESCIENCES, LLC. Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves Cardiovascular 07/22/2020 Cont f/u of SAPIEN 3 Bicuspid Registry 07/22/2020 Progress Adequate
CAP Cohort and Low Risk Bicuspid RWU Surveillance 07/22/2020 Progress Adequate
P140031
S112
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Cardiovascular 09/09/2020 SAPIEN 3 and SAPIEN 3 Ultra Aortic THV-in-THV Surv 09/09/2020 Progress Adequate
P140031
S125
EDWARDS LIFESCIENCES, LLC. SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Cardiovascular 05/13/2021 SAPIEN 3 & SAPIEN 3 Ultra Mitral ValveInRing Surv 05/13/2021 Progress Adequate
P140031
S141
EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Cardiovascular 07/28/2022 S3UR Real World Surveillance Protocol Pending
P140026
S016
SILK ROAD MEDICAL, INC ENROUTE Transcarotid Stent System Cardiovascular 04/28/2022 ROADSTER 3 PAS 04/28/2022 Study Pending
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 Post-Approval Study 03/17/2016 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
P140004 Boston Scientific Neuromodulation SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 Superion New Enrollment Study 12/15/2015 Progress Inadequate
P140003
S004
ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEMS Cardiovascular 04/07/2016 Impella AMI CS PAS 08/09/2016 Progress Adequate
P140003
S088
ABIOMED, INC. Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella 5.5 with SmartAssist System Cardiovascular 04/19/2022 Impella Real World Surveillance 08/18/2022 Study Pending
P130026
S070
St. Jude Medical TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ Cardiovascular 11/04/2021 SE Persistent AF PAS 08/17/2022 Study Pending
P130021
S002
Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 Comprehensive/Linked-Registry Based Surv 06/12/2014 Progress Adequate
P130021
S010
Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 03/30/2015 Comprehensive/Linked-Registry Progress Adequate
P130021
S014
Medtronic, Inc. COREVALVE (TM) EVOLUT(TM) R SYSTEM Cardiovascular 06/22/2015 Comprehensive/Linked-Registry Based Surv Progress Adequate
P130021
S016
Medtronic, Inc. MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS Cardiovascular 11/10/2015 Comprehensive/Linked-Registry Based Surv 11/02/2015 Progress Adequate
P130021
S025
Medtronic, Inc. Medtronic CoreValve Evolut R XL system Cardiovascular 10/26/2016 Continued f/u of premarket cohort 10/26/2016 Progress Adequate
Comprehensive/Linked-Registry Based Surv 10/26/2016 Progress Adequate
P130021
S029
Medtronic, Inc. 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 03/20/2017 Progress Adequate
P130021
S033
Medtronic, Inc. CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System Cardiovascular 07/10/2017 Cont f/u Intermediate Risk Cohort 07/10/2017 Progress Adequate
Intermediate Risk Surveillance 04/09/2018 Progress Adequate
P130021
S058
Medtronic, Inc. 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 08/16/2019 Progress Adequate
Evolut R and PRO Sys Registry-Based Low Risk RWU 08/16/2019 Progress Adequate
P130021
S076
Medtronic, Inc. Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System Cardiovascular 08/17/2020 Low Risk Real World Use Surveillance 08/17/2020 Progress Adequate
Cont F/u Low Risk Premarket Cohort 08/17/2020 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
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 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
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 WATCHMAN Comprehensive/Linked-Registry 03/18/2016 Progress Adequate
P130013
S035
Boston Scientific Corp. WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System Cardiovascular 07/21/2020 WATCHMAN FLX LAA Closure Device w/Delivery RW Use 05/21/2021 Progress Adequate
PINNACLE FLX Cont f/u of IDE Cohort 07/21/2020 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
P130009
S034
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 Comprehensive Linked Registry-Based Surv Progress Adequate
P130009
S037
EDWARDS LIFESCIENCES, LLC. SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 02/29/2016 New Enrollment SAPIEN XT Pulmonic PAS 09/20/2016 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
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 Progress Inadequate
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 Epi proColon PAS 10/18/2016 Progress Adequate
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Enhanced Safety Surveillance Study 06/11/2015 Progress Adequate
P120021 Abbott Medical AMPLATZER PFO OCCLUDER Cardiovascular 10/28/2016 Amplatzer PFO Occluder New Enrollment PAS 09/22/2017 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
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 Nit-Occlud PDA PAS 08/16/2013 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 Progress Adequate
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 Inadequate
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
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
P110019
S118
ABBOTT VASCULAR XIENCE Skypoint Everolimus Eluting Coronary Stent System Cardiovascular 03/11/2022 SPIRIT XLV PAS 05/06/2022 Study Pending
P110009 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Retrieval Analysis 08/23/2013 Progress Adequate
Enhanced Surveillance System 08/23/2013 Progress Adequate
P110008 Surgalign Spine Technologies, Inc. COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 Coflex Actual Practice PAS USA 08/05/2015 Progress Inadequate
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
P100047
S090
Medtronic HeartWare™ HVAD™ System Cardiovascular 09/27/2017 ENDURANCE PAS 07/26/2018 Progress Inadequate
P100045
S056
Abbott Medical CardioMEMs HF System Cardiovascular 02/18/2022 CMEMS RWE PAS 09/15/2022 Study Pending
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
P100040
S036
Medtronic Vascular Valiant Navion Thoracic Stent Graft System Cardiovascular 10/19/2018 Continued f/u Valiant EVO Study 10/19/2018 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
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 Adequate
P100018
S026
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR Pipeline Flex Embolization Device with Shield Technology Neurology 04/13/2021 Pipeline Flex Embolization w Shield Tech PAS 07/19/2021 Progress Adequate
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 PAS 02/11/2021 Study Pending
P100010
S110
Medtronic CryoCath LP Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter Cardiovascular 06/18/2021 Cryo Global Registry 12/16/2021 Study Pending
P100009 Abbott Medical MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 Comprehensive/Linked-Registry Based Surv 10/24/2013 Progress Adequate
P100009
S028
Abbott Medical 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 03/14/2019 Progress Adequate
Registry-Based CAP Cohort and RWU Surveillances 07/26/2019 Progress Adequate
P100006
S005
BIOMIMETIC THERAPEUTICS,LLC AUGMENT INJECTABLE Orthopedic 06/12/2018 Long-term PAS 06/11/2019 Progress Inadequate
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Enhanced Surveillance 09/28/2012 Progress Adequate
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
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 New Enrollment Study 06/25/2012 Progress Adequate
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
P080006
S129
MEDTRONIC Inc. Attain Stability Quad MRI SureScan Lead Cardiovascular 04/10/2019 Attain Stability Quad PAS 04/10/2019 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
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
P070008
S079
BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/ Quad LV 05/04/2017 Progress Adequate
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery
03/09/2012 Post-Approval PMA Cohorts Study (PACS) 03/09/2012 Progress Adequate
US Post-Approval Study (US-PAS) 03/09/2012 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
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
P050052
S049
MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
06/04/2015 Radiesse New Enrollment Study 11/23/2015 Progress Adequate
P050034 Samsara Vision Inc. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 IMT PAS 01 New Enrollment Study 07/01/2010 Progress Inadequate
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
P050023
S105
BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/Quad LV 05/04/2017 Progress Adequate
P050006
S060
W.L. GORE & ASSOCIATES,INC GORE CARDIOFORM Septal Occluder Cardiovascular 03/30/2018 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 05/28/2019 Progress Adequate
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
P040043
S051
W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 Comprehensive/Linked-Registry Based Surv 06/23/2014 Progress Adequate
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study 09/07/2007 Progress Inadequate
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 US Study 05/09/2006 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 Progress Adequate
P040003
S015
INSIGHTEC, LTD EXABLATE Obstetrics/
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08/31/2015 Post ExAblate Pregnancy Outcomes Registry 08/31/2015 Progress Inadequate
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 MemoryGel and Shape Glow Study 10/01/2014 Progress Inadequate
P030050
S002
Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 Clinical PAS 07/28/2009 Progress Adequate
P030050
S034
Q-Med AB Sculptra and Sculptra Aesthetic General &
Plastic Surgery
11/23/2021 Sculptra HF PAS 01/21/2022 Progress Adequate
P030031
S086
BIOSENSE WEBSTER, INC. Visitag Surpoint External Processing Unit (EPU) Cardiovascular 06/01/2018 VISITAG SURPOINT PAS 06/01/2018 Progress Adequate
P030031
S100
BIOSENSE WEBSTER, INC. THERMOCOOL SMARTTOUCH® SF Catheter Cardiovascular 09/30/2020 Real-World Experience of Catheter Ablation of PsAF 03/26/2021 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 Inadequate
P030016
S035
STAAR Surgical Company EVO/EVO+VISIAN Implantable Collamer Lens Ophthalmic 03/25/2022 CP22-01 Postmarket Evaluation of the EVO ICL 05/20/2022 Study Pending
CP19-01 PAS F/u of PMA Cohort 05/04/2022 Study Pending
P030011
S011
SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 Companion 2 Driver System PAS Protocol Pending
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 Natrelle and 410 Combined Cohort 08/03/2015 Progress Inadequate
Re-Op Phase 01/16/2015 Progress Adequate
P020024
S052
Abbott Medical AMPLATZER Piccolo Occluder Cardiovascular 01/11/2019 Continued FU of IDE/CAP cohort 01/11/2019 Progress Adequate
P020014
S041
BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
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06/29/2015 Post Approval Study 07/29/2015 Progress Adequate
P010031
S674
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt HF Quad CRT-D MRI SureScan (DTPB2QQ and DTPB2Ql); Cobalt HF CRT-D MRI SureScan (DTPB2D4 and DTPB2Dl); Crome HF Quad CRT-D MRI SureScan (DTPC2QQ and DTPC2Q1); and Crome HF CRT-D MRI SureScan (DTPC2D4 and DTPC2Dl) Implantable Pulse Generators with Cardiac Resynchronization Therapy; and Cobalt Crome Application Software Model D00U005 Cardiovascular 04/23/2020 iATP PAS 04/23/2020 Progress Adequate
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 Long Term PAS 04/21/2004 Progress Adequate
P010013
S041
HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
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02/01/2013 NovaSure PAS 02/01/2013 Progress Inadequate
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
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 MOUNTAIN PAS 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
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
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
H200001 Paragon 28, Inc. Patient Specific Talus Spacer Orthopedic 02/17/2021 Patient Specific Talus Spacer PAS 02/17/2021 Progress Adequate
H190005 Zimmer Biomet Spine, Inc. The Tether™ - Vertebral Body Tethering System Orthopedic 08/16/2019 The Tether Vertebral Tethering System PAS 01/13/2020 Progress Adequate
H190001 HDL Therapeutics, Inc. Plasma Delipidation System (PDS-2™ System) Gastroenterology/
Urology
12/01/2020 HALO-FHII PAS 10/04/2021 Progress Inadequate
HF PAS 12/05/2021 Progress Inadequate
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
H170001 ApiFix, Ltd. Minimally Invasive Deformity Correction (MID-C) System Orthopedic 08/23/2019 MID-C System Registry PAS 10/23/2019 Progress Adequate
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology
05/12/2017 Flourish Real-World Evidence PAS 10/02/2020 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


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