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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
Study Status
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 New Enrollment Study Progress Adequate
P180002 Pulmonx Corporation Zephyr Endobronchial Valve System Anesthesiology 06/29/2018 LIBERATE Extension Study Progress Adequate
ZEVR-Zephyr Valve Registry Progress Adequate
P180007 Gyrus ACMI, Inc. Spiration® Valve System Anesthesiology 12/03/2018 EMPROVE Extension Study Progress Adequate
SVS Post-Market Registry Study Progress Adequate
P180002  S005 Pulmonx Corporation Zephyr Endobronchial Valve (EBV) System Anesthesiology 07/30/2019 ZEVR-Zephyr Valve Registry Progress Adequate
P130008  S039 INSPIRE MEDICAL SYSTEMS Inspire Upper Airway Stimulation Anesthesiology 04/14/2020 Inspire Pediatric Post-Approval Registry Delayed
P120006  S031 Endologix, LLC Alto Abdominal Stent Graft System Cardiovascular 03/13/2020 Alto US and OUS Post-Approval Study 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 Progress Adequate
Evolut R and PRO Sys Registry-Based Low Risk RWU 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 Progress Adequate
SAPIEN 3 Registry-Based Cont Access & Low Risk RWU 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 Ongoing
New Enrollment IN.PACT AV Access PAS 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
P190015 Bolton Medical Inc. TREO® Abdominal Stent-Graft System Cardiovascular 05/04/2020 Cont F/u of the IDE Study Subjects Progress Adequate
TREO Post Approval Study 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 Ongoing
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 Ongoing
P190019 Boston Scientific Corporation Ranger™ Paclitaxel-Coated PTA Balloon Catheter Cardiovascular 10/30/2020 RANGER II SFA Cont F/u Study Ongoing
Range Long Balloon, Ranger China & COMPARE I f/u Ongoing
P190020 Biosensors International USA, Inc. BioFreedom Drug Coated Coronary Stent System Cardiovascular 04/14/2022 LEADERS FREE II (LFII) Clinical Study Study Pending
P150003  S054 BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System Cardiovascular 01/22/2021 Synergy Megatron PAS Progress Adequate
P190023 Abbott Medical Portico Transcatheter Aortic Valve Implantation System Cardiovascular 09/17/2021 Cont f/u of the PORTICO IDE cohorts Progress Adequate
Registry-Based Real World use Surv of the Portico Ongoing
P150005  S049 Boston Scientific Corp. IntellaNav MiFi Open-Irrigated Ablation Catheter Cardiovascular 04/17/2020 DirectSense RF Sub-study 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 Study Pending
P150033  S061 MEDTRONIC Inc. Micra Transcatheter Pacing System, Micra AV Application Software Cardiovascular 01/15/2020 Micra AV Post Approval Study Progress Adequate
P150026  S008 CARDIOFOCUS, INC. HeartLight Endoscopic Ablation System Cardiovascular 05/08/2020 HeartLight X3 PAS Progress Adequate
P180050 CVRx, INC. BAROSTIM NEO® System Cardiovascular 08/16/2019 Extended Phase BeAT-HF PAS Progress Adequate
P180051 TransMedics, Inc. Organ Care System (OCS) Heart System Cardiovascular 09/03/2021 OCS Heart EXPAND+CAP Continued f/u PAS Progress Adequate
Post-commercialization DBD New Enrollment Study Progress Adequate
P170042  S002 C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 03/01/2019 AVeNEW PAS Progress Adequate
P100009  S028 Abbott Medical MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System Cardiovascular 03/14/2019 Registry-Based CAP Cohort and RWU Surveillances Progress Adequate
Cont f/u of the COAPT Trival Pivotal Cohort Progress Adequate
P150005  S035 Boston Scientific Corp. Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters Cardiovascular 08/01/2018 INTERRUPT AF PAS Progress Adequate
P020024  S052 Abbott Medical AMPLATZER Piccolo Occluder Cardiovascular 01/11/2019 Continued FU of IDE/CAP cohort Progress Adequate
P180036 Impulse Dynamics (USA), Inc. OPTIMIZER Smart System Cardiovascular 03/21/2019 OPTIMIZER System PAS Progress Adequate
P140031  S074 EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Cardiovascular 12/27/2018 SAPIEN 3 Ultra Novel Surveillance Progress Adequate
P080006  S129 MEDTRONIC Inc. Attain Stability Quad MRI SureScan Lead Cardiovascular 04/10/2019 Attain Stability Quad PAS Progress Adequate
P200002 AtriCure, Inc. EPi-Sense Guided Coagulation System Cardiovascular 04/28/2021 CONVERGE Post-Approval Study 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 Progress Adequate
P030031  S100 BIOSENSE WEBSTER, INC. THERMOCOOL SMARTTOUCH® SF Catheter Cardiovascular 09/30/2020 Real-World Experience of Catheter Ablation of PsAF 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 Progress Adequate
CAP Cohort and Low Risk Bicuspid RWU Surveillance 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 Progress Adequate
SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION 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 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 Progress Adequate
Cont F/u Low Risk Premarket Cohort Progress Adequate
P200028 Medtronic Inc. DiamondTemp Ablation System Cardiovascular 01/28/2021 DIAMOND AF PAS Study Pending
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 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 Progress Adequate
P100010  S110 Medtronic CryoCath LP Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter Cardiovascular 06/18/2021 Cryo Global Registry Study Pending
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 Progress Adequate
P200045 Bolton Medical, Inc. RelayPro Thoracic Stent-Graft System Cardiovascular 08/05/2021 Continued f/u of the IDE Study Subjects Progress Adequate
RelayPro Post-Approval Surveillance Study Progress Adequate
P200046 Medtronic, Inc. Harmony™ TPV System Cardiovascular 03/26/2021 Continued Follow-up of the Harmony TPV IDE Cohort Progress Adequate
Harmony TPV New Enrollment Study Progress Adequate
P200037 Kestra Medical Technologies, Inc. ASSURE Wearable Cardioverter Defibrillator (WCD) System Cardiovascular 07/27/2021 ACE-PAS 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 Progress Adequate
DISRUPT CAD III Cont f/u Study Progress Adequate
P200049 Abbott Medical Amplatzer™ Amulet™ Left Atrial Appendage Occluder Cardiovascular 08/14/2021 Continued Follow-up of the Amulet IDE Cohort Progress Adequate
Amulet Real-World Use Surveillance Study Pending
P140026  S016 SILK ROAD MEDICAL, INC ENROUTE Transcarotid Stent System Cardiovascular 04/28/2022 ROADSTER 3 PAS Ongoing
P210006 Vascutek Ltd. Thoraflex™ Hybrid Cardiovascular 04/19/2022 EXTEND Post-Approval Study Ongoing
P130013  S043 Boston Scientific Corp. WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems Cardiovascular 09/02/2022 WATCHMAN FLX NESTed DAPT PAS Study Pending
P130026  S070 St. Jude Medical TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ Cardiovascular 11/04/2021 SE Persistent AF (PsAF) PAS Study Pending
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 Study Pending
P210015 Avive Solutions, Inc. Avive Automated External Defibrillator (AED) System Cardiovascular 10/31/2022 Avive AED Post-Approval Study Study Pending
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 Study Pending
Alterra New Enrollment Study Study Pending
P100045  S056 Abbott Medical CardioMEMs HF System Cardiovascular 02/18/2022 CMEMS RWE PAS Study Pending
P110019  S118 ABBOTT VASCULAR XIENCE Skypoint Everolimus Eluting Coronary Stent System Cardiovascular 03/11/2022 SPIRIT XLV PAS 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 Study Pending
P170011  S035 Abiomed, Inc. Impella RP System, Impella RP with SmartAssist System Cardiovascular 04/19/2022 Impella Real World Surveillance 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 Study Pending
Post-Market Surveillance Study Study Pending
P180051  S001 TransMedics, Inc. OCS Heart System Cardiovascular 04/27/2022 OCS-HEART-03-PAS Study Pending
Post-commercialization DCD New Enrollment Study Progress Adequate
P210039 TriReme Medical, LLC Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) Cardiovascular 11/04/2022 The Chocolate Touch Continued Follow-up Study Study Pending
P220003 Edwards LifeSciences LLC PASCAL Precision Transcatheter Valve Repair System Cardiovascular 09/14/2022 Continued Follow-up of the CLASP III Trial Cohort Study Pending
Registry-Based Real-World Use Surveillance Study Pending
P140031  S141 EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Cardiovascular 07/28/2022 S3UR Real World Surveillance Study Pending
P150048  S012 EDWARDS LIFESCIENCES, LLC. Edwards Pericardial Mitral Bioprosthesis, Model 11000M Cardiovascular 08/09/2018 Mitral Model 11000M, Cont f/u Post-Approval Study 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 Ongoing
P180011 Boston Scientific Corp. Eluvia Drug-Eluting Vascular Stent System Cardiovascular 09/18/2018 IMPERIAL Continued f/u study Progress Adequate
REGAL and EMINENT Long Term f/u studies Progress Adequate
P100040  S036 Medtronic Vascular Valiant Navion Thoracic Stent Graft System Cardiovascular 10/19/2018 Continued f/u Valiant EVO Study Progress Adequate
P160054  S008 Abbott Medical HeartMate 3 Left Ventricular Assist System Cardiovascular 10/18/2018 Continued f/u of Premarket Pivotal Cohort Progress Adequate
P180001 WILLIAM COOK EUROPE APS Zenith Dissection Endovascular System Cardiovascular 12/31/2018 SVS VQI Postmarket Surveillance Progress Adequate
P170038 Abbott CentriMag Circulatory Support System Cardiovascular 12/06/2019 CentriMag FTW PAS Progress Adequate
P910073  S145 BOSTON SCIENTIFIC Reliance 4- Front Lead Family and Suture Sleeve Accessory Cardiovascular 05/04/2018 MOUNTAIN PAS 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 Progress Adequate
HALO PAS Progress Adequate
P050006  S060 W.L. GORE & ASSOCIATES,INC GORE CARDIOFORM Septal Occluder Cardiovascular 03/30/2018 GORE CARDIOFORM New Enrollment PAS Progress Adequate
P150026  S002 CARDIOFOCUS, INC. Heart Light Catheter with Excalibur Balloon Cardiovascular 05/02/2018 CF HeartLight PAS Progress Adequate
P160015  S001 ZOLL MEDICAL CORPORATION AED 3 defibrillator Cardiovascular 02/28/2020 AED 3 and Pad Placement PAS Progress Adequate
P170027 TherOx, Inc. TherOx Downstream System Cardiovascular 04/02/2019 New Enrollment Study Ongoing
P170030 Biotronik, Inc ORSIRO Sirolimus Eluting Coronary Stent System Cardiovascular 02/22/2019 Bioflow-VII New Enrollment PAS 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 Progress Adequate
SAPIEN 3 Aortic Valve-in-Valve Comp Surv Progress Adequate
P100021  S063 Medtronic Vascular Endurant II/IIs Stent Graft System Cardiovascular 09/29/2017 Cont f/u ANCHOR Reg Short Neck Cohort Progress Adequate
P160043  S001 MEDTRONIC VASCULAR Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular 11/16/2017 RESOLUTE ONYX PAS Progress Adequate
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 Micra Transcatheter Pacing System PAS 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
P150035 Abbott Medical Aveir VR Leadless System Cardiovascular 03/31/2022 The Aveir VR RWE Study Progress Adequate
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 Progress Adequate
PAS Aortic Continued Follow-up Progress Adequate
P140031  S010 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort Progress Adequate
Comprehensive/Linked-Registry Based Surv 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 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
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
P130009  S057 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort Progress Adequate
Comprehensive/Linked-Registry Based Surv Progress Adequate
P160043 MEDTRONIC VASCULAR RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 04/28/2017 RESOLUTE ONYX PAS Progress Adequate
P130021  S025 Medtronic, Inc. Medtronic CoreValve Evolut R XL system Cardiovascular 10/26/2016 Comprehensive/Linked-Registry Based Surv Progress Adequate
P960040  S385 BOSTON SCIENTIFIC NG4 Family of Pulse Generators ICDS. Cardiovascular 05/02/2017 MANAGE-HF Progress Adequate
P010012  S436 Boston Scientific Corp. NG4 Family of Pulse Generators CRT-DS Cardiovascular 05/02/2017 MANAGE-HF 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 Ongoing
P050023  S105 BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/Quad LV Ongoing
P890003  S372 Medtronic, Inc. SYNERGYST II PULSE GENERATOR Cardiovascular 09/01/2017 Heart Failure Risk Status (HFRS) PAS Progress Adequate
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 New Enrollment PAS Registry Progress Inadequate
P100047  S090 Medtronic HeartWare™ HVAD™ System Cardiovascular 09/27/2017 ENDURANCE PAS 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 Inadequate
P130021  S029 Medtronic, Inc. Medtronic CoreValve Evolut PRO System Cardiovascular 03/20/2017 Comprehensive/Linked-Registry Based Surv 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 Progress Adequate
P150005  S014 Boston Scientific Corp. Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter Cardiovascular 12/21/2017 INTERRUPT (Zero) AF PAS 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 Progress Adequate
Intermediate Risk Surveillance Progress Adequate
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 Comprehensive/Linked-Registry Based Surv Progress Adequate
P000037  S030 On-X Life Technologies, Inc. ON-X PROSTHETIC HEART VALVE Cardiovascular 04/01/2015 Newly Enrolled On-X PAS Progress Adequate
P120021 Abbott Medical AMPLATZER PFO OCCLUDER Cardiovascular 10/28/2016 Amplatzer PFO Occluder New Enrollment PAS Progress Adequate
P070014  S037 BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 Popliteal Indication PAS Surv Project Progress Adequate
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 WATCHMAN New Enrollment (NESTed-PAS) Redesigned/Replaced Study
WATCHMAN Comprehensive/Linked-Registry Progress Adequate
P040043  S051 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 Comprehensive/Linked-Registry Based Surv 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 Ongoing
P980023  S057 BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 Protego DF4 Post Approval Registry Ongoing
P130021  S002 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 Comprehensive/Linked-Registry Based Surv Progress Adequate
P130021 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 Contined f/u of IDE pivotal cohort Redesigned/Replaced Study
Continued f/u of continued access cohort Redesigned/Replaced Study
P100040  S012 Medtronic Vascular VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 Comprehensive/Linked-Registry Based Surv. Progress Adequate
P140003 ABIOMED, INC. IMPELLA 2.5 System Cardiovascular 03/23/2015 New Enrollment Study Redesigned/Replaced Study
P130021  S010 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 03/30/2015 Comprehensive/Linked-Registry Progress Adequate
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 Comprehensive/Linked-Registry 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 Progress Adequate
P150002 Cordis US Corporation INCRAFT(R) AAA STENT GRAFT SYSTEM Cardiovascular 11/27/2018 INCRAFT US Post-Approval Study Study Pending
Long Term INSPIRATION Study Progress Adequate
P150009 ANGEL MEDICAL SYSTEMS INC. ANGELMED GUARDIAN SYSTEM Cardiovascular 04/09/2018 AngelMed Guardian PAS Ongoing
P130009  S034 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 Comprehensive Linked Registry-Based Surv Progress Adequate
P130021  S014 Medtronic, Inc. COREVALVE (TM) EVOLUT(TM) R SYSTEM Cardiovascular 06/22/2015 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 Progress Adequate
P150023 ABBOTT VASCULAR INC. ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM Cardiovascular 07/05/2016 ABSORB IV Post-Approval Study Progress Adequate
P130021  S016 Medtronic, Inc. MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS Cardiovascular 11/10/2015 Comprehensive/Linked-Registry Based Surv Progress Adequate
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 PAS of HeartLight Endoscopic Ablation Sys 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 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 Progress Adequate
Cont f/u of premarket cohorts w/stent fra Progress Adequate
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study Progress Inadequate
P860057  S029 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term 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 Progress Adequate
P870072  S037 THORATEC LABORATORIES CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 Thoratec TLC-ii portable Progress Adequate
P100009 Abbott Medical MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 Comprehensive/Linked-Registry Based Surv Progress Adequate
P010012  S230 Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 MADIT-CRT ACC NCDR 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 Redesigned/Replaced Study
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 Relay Thoracic Stent-Graft w Plus Del Sys Progress Adequate
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 Nit-Occlud PDA PAS Progress Adequate
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 PAS of TS Feat. w Sensor-Augment Pump Sys Redesigned/Replaced Study
P160048 Senseonics, Incorporated EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 06/21/2018 Post-Approval Study Progress Inadequate
P160017 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 09/28/2016 MiniMed 670G Post Approval Study Progress Inadequate
P160030 ABBOTT DIABETES CARE INC. Freestyle Libre Flash Glucose Monitoring System Clinical Chemistry 09/27/2017 FreeStyle Libre Flash Glucose Monitoring 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 Delayed
P160017  S031 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 06/21/2018 Post-Approval Study Progress Inadequate
P160048  S006 Senseonics, Incorporated Eversense Continuous Glucose Monitoring System Clinical Chemistry 06/06/2019 Eversense CGM Non-Adjunctive PAS 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 Progress Adequate
P200021 Oticon Medical Neuro Cochlear Implant System Ear Nose & Throat 06/23/2021 New Enrollment Study Study Pending
P970051  S205 Cochlear Americas Nucleus 24 Cochlear Implant System Ear Nose & Throat 01/10/2022 Cochlear New Enrollment SSD/UHL Study Ongoing
P970051  S172 Cochlear Americas NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/17/2020 Nucleus 24 Pediatric Post-Approval Study Progress Adequate
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 New Enrollment Redesigned/Replaced Study
P130016 Cochlear Americas NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 New Enrollment Study Progress Adequate
P130018 UROMEDICA INC PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN Gastroenterology/
Urology
11/24/2015 ProAct Post-Approval Study Progress Inadequate
H120005 KANEKA PHARMA AMERICA LLC LIPOSORBER LA-15 SYSTEM Gastroenterology/
Urology
10/10/2013 New Enroll. PAS for Liposorber LA-15 Sys Progress Adequate
H130001 KANEKA PHARMA AMERICA LLC KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN Gastroenterology/
Urology
03/05/2015 New Enrollment Study Progress Inadequate
P970004  S022 MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology
09/24/2002 Urgency Frequency (UF 1635) Redesigned/Replaced Study
Urinary Urge Incontinence (UUI) Redesigned/Replaced Study
P000008 ReShape Lifesciences, Inc. LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology
06/05/2001 Lap-Band Long Term Redesigned/Replaced Study
H170002 Kaneka Pharma America LLC LIPOSORBER LA-15 System Gastroenterology/
Urology
03/20/2018 New Enroll PAS LIPOSORBER LA-15 Adults Progress Adequate
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology
05/12/2017 Flourish Real-World Evidence PAS Progress Adequate
Flourish Post-Approval Study Redesigned/Replaced Study
P180014 XVIVO Perfusion, Inc. XPS™ with Steen Solution™ Perfusate Gastroenterology/
Urology
04/26/2019 Long Term Eval PAS of XPS System Progress Adequate
NOVEL/NOVEL Ext Cont Long Term PAS Progress Adequate
P160013 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology
03/22/2018 TOP PAS Registry Progress Inadequate
P210020 Urotronic, Inc. Optilume Urethral Drug Coated Balloon Gastroenterology/
Urology
12/03/2021 ROBUST-LT Post-Approval Study (PR1277) Study Pending
URINATE PAS (PR1276) Progress Adequate
STREAM PAS (PR1275) Progress Adequate
P200035 OrganOx Limited OrganOx metra System Gastroenterology/
Urology
12/09/2021 WP01 Long-Term Follow-up PAS Ongoing
New Enrollment PAS Study Pending
P200036 Valencia Technologies Corporation eCoin Peripheral Neurostimulator Gastroenterology/
Urology
03/01/2022 Continued Follow-Up of G170301 Clinical Study Ongoing
Post-Approval Study of eCoin-RECIPE Study Pending
P200031 TransMedics, Inc. Organ Care System (OCS™) Liver Gastroenterology/
Urology
09/28/2021 PROTECT CAP Continuation PAS Progress Adequate
OLP New Enrollment PAS Progress Adequate
P160013  S002 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology
05/31/2019 OCS-LUNG-PAS Progress Inadequate
H190001 HDL Therapeutics, Inc. Plasma Delipidation System (PDS-2™ System) Gastroenterology/
Urology
12/01/2020 HALO-FHII PAS Progress Adequate
HF PAS Study Pending
P190012 Spatz FGIA Inc. Spatz3 Adjustable Balloon System Gastroenterology/
Urology
10/15/2021 Spatz3 Post-Approval Study Delayed
P030050  S034 Q-Med AB Sculptra and Sculptra Aesthetic General &
Plastic Surgery
11/23/2021 Sculptra HF PAS Progress Adequate
P050052  S049 MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
06/04/2015 Radiesse New Enrollment Study Progress Adequate
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 Natrelle and 410 Combined Cohort Progress Inadequate
BIFS (Large PAS) Redesigned/Replaced Study
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 MemoryGel and Shape Glow Study Progress Inadequate
Large PAS Redesigned/Replaced Study
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 Natrelle and 410 Combined Cohort Progress Inadequate
P030050  S002 Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 Clinical PAS Progress Adequate
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery
06/14/2013 MemoryGel and Shape Glow Study Progress Inadequate
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery
03/09/2012 Post-Approval PMA Cohorts Study (PACS) Progress Adequate
US Post-Approval Study (US-PAS) Progress Inadequate
P120011 IDEALIMPLANT IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT General &
Plastic Surgery
11/14/2014 Post-Approval PMA Cohort Study (PACS) Progress Adequate
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 Prometra Programmable Pump system Progress Adequate
Extended Use Stability Study Progress Adequate
Leachables Study Progress Adequate
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 New Enrollment - All Comers Progress Adequate
New Enrollment -Performance & Programming Progress Adequate
P100034 Novocure GmbH NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 New Enrollment Study for NovoTTF-100A Redesigned/Replaced Study
P960009  S219 MEDTRONIC Inc. MEDTRONIC DBS THERAPY FOR EPILEPSY Neurology 04/27/2018 DBS for Epilepsy New Enrollment PAS Delayed
P150004 Abbott Medical Axium Neurostimulator System Neurology 02/11/2016 F/U Axium Neurostimulator System (FANS) Progress Adequate
P150038 InSightec EXABLATE Neurology 07/11/2016 Long Term PAS Progress Adequate
P150038  S006 InSightec ExAblate Neurology 12/16/2018 PAS Registry Study for ExAblate 4000 Delayed
P170013 MicroVention, Inc. Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. Neurology 05/30/2018 PAS-Post-Market Surveillance Study/LongTerm Safety Progress Adequate
P170032 MicroVention, Inc. Woven EndoBridge (WEB) Aneurysm Embolization System Neurology 12/31/2018 PAS1 - PostMarket Surveillance-Long Term Safety Progress Adequate
PAS2 - WEB-IT Study Progress Adequate
P150038  S014 InSightec Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Neurology 10/29/2021 ExAblate Neuro PAS Study Pending
P180027  S002 MicroVention, Inc. Flow Re-Direction Endoluminal Device (FRED®) System Neurology 09/16/2021 FRED X PAS 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 Ongoing
P180031 Stryker Neurovascular Neuroform Atlas® Stent System Neurology 05/16/2019 ATLAS Study Progress Adequate
P040003  S015 INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
08/31/2015 Post ExAblate Pregnancy Outcomes Registry Progress Inadequate
P020014  S041 BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/29/2015 Post Approval Study Progress Adequate
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology
11/18/2011 Deep Hyperthermia and Radiation Redesigned/Replaced Study
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 New Enrollment Study Progress Adequate
Registry Study Redesigned/Replaced Study
P030016  S001 STAAR Surgical Company Visian Toric ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 09/13/2018 Visian Toric ICL New Enrollment PAS Progress Adequate
P050034 Samsara Vision Inc. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 IMT PAS 01 New Enrollment Study Progress Inadequate
P130004 OCULAR THERAPEUTIX, INC. RESURE SEALANT Ophthalmic 01/08/2014 Device Exposure Registry Study Redesigned/Replaced Study
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 Progress Adequate
P930016  S053 AMO Manufacturing USA, LLC iDESIGNRefractive Studio, STAR Excimer Laser System Ophthalmic 06/15/2018 Post-Approval Study Progress Inadequate
P160055 RxSight, Inc. LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) Ophthalmic 11/22/2017 LAL/LDD Postmarket RCT Progress Inadequate
P170034 Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC HYDRUS MICROSTENT Ophthalmic 08/10/2018 Modified Hydrus New Enrollment PAS Progress Adequate
P150040  S003 Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser Ophthalmic 10/04/2018 VisuMax SMILE New Enrollment Progress Inadequate
P170043 Glaukos Corporation iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) Ophthalmic 06/21/2018 Extended f/u Premarket Cohort Progress Inadequate
New Enrollment PAS Ongoing
P170039 HumanOptics AG CustomFlex Artificial Iris Ophthalmic 05/30/2018 PAS, Adult and Pediatric Progress Inadequate
Pediatric New Enrollment Progress Inadequate
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 Progress Adequate
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 CyPass Micro Stent New Enrollment PAS Progress Adequate
COMPASS XXT Post-Approval Study Progress Adequate
P030016  S035 STAAR Surgical Company EVO/EVO+VISIAN Implantable Collamer Lens Ophthalmic 03/25/2022 CP22-01 Postmarket Evaluation of the EVO ICL Progress Adequate
CP19-01 PAS F/u of PMA Cohort 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 Progress Inadequate
MiSight 1 Day Safety PAS Progress Inadequate
P200020 Lenstec, Inc. SBL-3 Multifocal Intraocular Lens Ophthalmic 07/22/2022 Lenstec SBL-3 PAS Study Pending
P210005 AcuFocus, Inc. IC-8 Apthera Intraocular Lens (IOL) Ophthalmic 07/22/2022 Continuation Study - SAIL-101-PAS Study Pending
New Enrollment Study-IC-8 Apthera IOL Ongoing
P200022  S003 NuVasive, Inc. Simplify Cervical Artificial Disc Orthopedic 04/01/2021 Extended f/u of the 2-Level Simplify Progress Adequate
P200022 NuVasive, Inc. Simplify® Cervical Artificial Disc Orthopedic 09/18/2020 Extended Follow-up of IDE Subjects Progress Adequate
H200001 Paragon 28, Inc. Patient Specific Talus Spacer Orthopedic 02/17/2021 Patient Specific Talus Spacer PAS Progress Adequate
H190005 Zimmer Biomet Spine, Inc. The Tether™ - Vertebral Body Tethering System Orthopedic 08/16/2019 The Tether Vertebral Tethering System PAS Progress Adequate
P190009 Integrum AB OPRA Implant System Orthopedic 12/18/2020 Osseointegration Quality Registry PAS Progress Adequate
TFAOS PAS Progress Adequate
P210034 CartiHeal Ltd. Agili-C Orthopedic 03/29/2022 Extended Follow-up of the Premarket Cohort Ongoing
P090029  S006 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 12/15/2016 Device Failure and Complaint Analysis Progress Adequate
P160036 DT MedTech LLC Hintermann Series H3 Total Ankle Replacement System Orthopedic 06/04/2019 Hintermann Series H3 TAR Long Term Study Progress Adequate
Hintermann Series H3 TAR Performance Study Progress Adequate
P100006  S005 BIOMIMETIC THERAPEUTICS,LLC AUGMENT INJECTABLE Orthopedic 06/12/2018 Long-term PAS Progress Inadequate
P160050 INTRINSIC THERAPEUTICS BARRICAID ANULAR CLOSURE DEVICE (ACD) Orthopedic 02/08/2019 Extended F/U-Barricaid ACD Premarket Cohort Progress Inadequate
Histological and Retrieval Analysis PAS Progress Adequate
H170001 ApiFix, Ltd. Minimally Invasive Deformity Correction (MID-C) System Orthopedic 08/23/2019 MID-C System Registry PAS Progress Adequate
P170036 Spinal Kinetics LLC M6-C Artificial Cervical Disc Orthopedic 02/06/2019 M6-C Artificial Cervical Disc-Extended Follow-up Progress Adequate
P140004 Boston Scientific Neuromodulation SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 Superion New Enrollment Study Progress Inadequate
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 Post-Approval Study Progress Adequate
P090029  S003 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP(TM) CERVICAL DISC Orthopedic 07/07/2016 PRESTIGE LP 2-Level Metal Concentrations Progress Adequate
P150030 Smith & Nephew, Inc. R3 DELTA CERAMIC HIP SYSTEM Orthopedic 10/17/2016 Long-Term F/u of EU patients PAS Progress Adequate
Short to Mid-Term f/u of New US Patients Delayed
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Enhanced Safety Surveillance Study Progress Adequate
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Long Term Redesigned/Replaced Study
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Duraloc Long Term Redesigned/Replaced Study
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 US Study Progress Adequate
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Long term Redesigned/Replaced Study
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 Long term Redesigned/Replaced Study
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 Long Term PAS Progress Adequate
P110002 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Enhanced Surveillance System Progress Adequate
Retrieval Analysis Progress Adequate
P110008 Surgalign Spine Technologies, Inc. COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 Coflex Actual Practice PAS Redesigned/Replaced Study
Coflex Actual Practice PAS USA Progress Inadequate
P110009 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Retrieval Analysis Progress Adequate
Enhanced Surveillance System 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 Progress Inadequate
P090029 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 07/24/2014 Enhanced Surveillance Study Redesigned/Replaced Study
Device Failure Redesigned/Replaced Study
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Enhanced Surveillance Progress Adequate
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 Epi proColon PAS Progress Adequate
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 Cologuard PAS Progress Inadequate
P210001  S001 Ventana Medical Systems Inc (Roche Tissue Diagnostics) VENTANA MMR RxDx Panel Pathology 03/21/2022 KEYTRUDA PAS Study Pending
P130017  S029 Exact Sciences Corporation Cologuard Stool DNA-Based Colorectal Cancer Screening Test Pathology 09/20/2019 A Post-Marketing Real World Study 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 NTRK Clinical Efficacy PAS for Larotrectinib Delayed
P170019  S029 Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 02/18/2022 MK-3475 MSI-H FMI F1CDx Post Approval Analysis Study Pending
P200029 Boston Scientific Corporation TheraSphere Radiology 03/17/2021 The Patient Exposure Study Progress Inadequate


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Food and Drug Administration
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Email: MandatedStudiesPrograms@fda.hhs.gov

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