f Post-Approval Studies (PAS) Database
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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		 Sort By Date Order -- Descending
Study
Name
Study Status
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology		 11/18/2011 Deep Hyperthermia and Radiation Redesigned/Replaced Study
H120005 KANEKA PHARMA AMERICA LLC LIPOSORBER LA-15 SYSTEM Gastroenterology/
Urology		 10/10/2013 New Enroll. PAS for Liposorber LA-15 Sys Ongoing
H130001 KANEKA PHARMA AMERICA LLC KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN Gastroenterology/
Urology		 03/05/2015 New Enrollment Study Delayed
H150003 WILSON-COOK MEDICAL INC. Flourish Pediatric Esophageal Atresia Anastomosis Device Gastroenterology/
Urology		 05/12/2017 Flourish Real-World Evidence PAS Delayed
Flourish Post-Approval Study Redesigned/Replaced Study
H170001 ApiFix, Ltd. Minimally Invasive Deformity Correction (MID-C) System Orthopedic 08/23/2019 MID-C System Registry PAS Delayed
H170002 Kaneka Pharma America LLC LIPOSORBER LA-15 System Gastroenterology/
Urology		 03/20/2018 New Enroll PAS LIPOSORBER LA-15 Adults Ongoing
H190001 HDL Therapeutics, Inc. Plasma Delipidation System (PDS-2™ System) Gastroenterology/
Urology		 12/01/2020 HALO-FHII PAS Hold
HF PAS Hold
H190005 Zimmer Biomet Spine, Inc. The Tether™ - Vertebral Body Tethering System Orthopedic 08/16/2019 The Tether Vertebral Tethering System PAS Delayed
H200001 Paragon 28, Inc. Patient Specific Talus Spacer Orthopedic 02/17/2021 Patient Specific Talus Spacer PAS Delayed
H210002 Globus Medical, Inc. REFLECT™ Scoliosis Correction System Orthopedic 05/15/2023 REFLECT Scoliosis Correction System Registry PAS Delayed
H220001 TheraBionic, Inc. TheraBionic P1 General &
Plastic Surgery		 09/26/2023 The TheraBionic P1 Post-Approval Study Protocol Pending
H230003 restor3d, Inc. restor3d Total Talus Replacement Orthopedic 11/17/2023 Total Talus Replacement (TTR) PAS Study Pending
P000008 ReShape Lifesciences, Inc. LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology		 06/05/2001 Lap-Band Long Term Redesigned/Replaced Study
P000025  S104 MED-EL CORP. MED-EL Cochlear Implant System Ear Nose & Throat 07/19/2019 MED-EL New Enrollment SSD/AHL Study Ongoing
P000037  S030 On-X Life Technologies, Inc. ON-X PROSTHETIC HEART VALVE Cardiovascular 04/01/2015 Newly Enrolled On-X PAS Ongoing
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
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery		 11/17/2006 Natrelle and 410 Combined Cohort Ongoing
BIFS (Large PAS) Redesigned/Replaced Study
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
P030016  S001 STAAR Surgical Company Visian Toric ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 09/13/2018 Visian Toric ICL New Enrollment PAS Ongoing
P030016  S035 STAAR Surgical Company EVO/EVO+VISIAN Implantable Collamer Lens Ophthalmic 03/25/2022 CP19-01 PAS F/u of PMA Cohort Ongoing
CP22-01 Postmarket Evaluation of the EVO ICL Ongoing
P030031  S100 BIOSENSE WEBSTER, INC. THERMOCOOL SMARTTOUCH® SF Catheter Cardiovascular 09/30/2020 Real-World Experience of Catheter Ablation of PsAF Ongoing
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery		 11/17/2006 MemoryGel and Shape Glow Study Ongoing
Large PAS Redesigned/Replaced Study
P040002  S070 Endologix, LLC AFX2 Endovascular AAA System Cardiovascular 12/06/2022 VQI and VISION EVAR Registry Analysis Ongoing
P040003  S015 INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology		 08/31/2015 Post ExAblate Pregnancy Outcomes Registry Delayed
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Duraloc Long Term Redesigned/Replaced Study
P040033 Smith & Nephew, Inc. BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 US Study Ongoing
P040040 Abbott Medical AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study Ongoing
P040043  S051 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 Comprehensive/Linked-Registry Based Surv Ongoing
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery		 02/20/2013 Natrelle and 410 Combined Cohort Ongoing
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
P050006  S060 W.L. GORE & ASSOCIATES,INC GORE CARDIOFORM Septal Occluder Cardiovascular 03/30/2018 GORE CARDIOFORM New Enrollment PAS 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
P050034 Samsara Vision Inc. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 IMT PAS 01 New Enrollment Study Delayed
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Long Term Redesigned/Replaced Study
P050050 DJO Global SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 Actual Conditions of Use Study (STAR 2) Delayed
P050050  S024 DJO Global Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) Orthopedic 11/13/2023 S.T.A.R. Ankle PAS Study Pending
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
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery		 06/14/2013 MemoryGel and Shape Glow Study Ongoing
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery		 03/09/2012 US Post-Approval Study (US-PAS) Delayed
P070008  S079 BIOTRONIK, INC. PACEMAKER ICD CRT NON IMPLANTED COMPONENTS Cardiovascular 05/04/2017 QP ExCELS Sentus QP Ext CRT w/ Quad LV Ongoing
P070026  S004 DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 Short-Mid-Term F/u of New COC36 patients Ongoing
P080006  S129 MEDTRONIC Inc. Attain Stability Quad MRI SureScan Lead Cardiovascular 04/10/2019 Attain Stability Quad PAS Ongoing
P080012 Algorithm Sciences, Inc. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 Extended Use Stability Study Hold
Prometra Programmable Pump System Ongoing
Leachables Study Ongoing
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 Registry Study Redesigned/Replaced Study
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 New Enrollment Redesigned/Replaced Study
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
P090029  S006 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 12/15/2016 Device Failure and Complaint Analysis Ongoing
P100006  S005 BIOMIMETIC THERAPEUTICS,LLC AUGMENT INJECTABLE Orthopedic 06/12/2018 Long-term PAS Delayed
P100009 Abbott Medical MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 Comprehensive/Linked-Registry Based Surv 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 Ongoing
P100010  S098 Medtronic CryoCath LP Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters Cardiovascular 06/23/2020 STOP Persistent AF PAS Ongoing
P100010  S110 Medtronic CryoCath LP Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter Cardiovascular 06/18/2021 STOP AF First PAS Ongoing
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
P100018  S034 Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR Pipeline Vantage Embolization Device with Shield Technology Neurology 09/15/2023 INSPIRE Pipeline Vantage Embolization Device PAS Protocol Overdue
P100021  S063 Medtronic Vascular Endurant II/IIs Stent Graft System Cardiovascular 09/29/2017 Cont f/u ANCHOR Reg Short Neck Cohort Ongoing
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 New Enrollment - All Comers Delayed
New Enrollment -Performance & Programming Delayed
P100034 Novocure GmbH NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 New Enrollment Study for NovoTTF-100A 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
P100045  S056 Abbott Medical CardioMEMs HF System Cardiovascular 02/18/2022 CMEMS RWE PAS Ongoing
P100047  S090 Medtronic HeartWare™ HVAD™ System Cardiovascular 09/27/2017 ENDURANCE PAS Ongoing
P110002 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Enhanced Surveillance System Ongoing
Retrieval Analysis Ongoing
P110008 Xtant Medical Holdings, Inc. COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 Coflex Actual Practice PAS USA Delayed
Coflex Actual Practice PAS Redesigned/Replaced Study
P110009 Zimmer Biomet Spine, Inc. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Enhanced Surveillance System Ongoing
Retrieval Analysis Ongoing
P110016  S080 Abbott Medical FlexAbility™ Ablation Catheter, Sensor Enabled™ Cardiovascular 12/14/2022 LESS VT NICM Post-Approval Study Ongoing
LESS VT Continued F/u of IDE Study Pending
P110019  S118 ABBOTT VASCULAR XIENCE Skypoint Everolimus Eluting Coronary Stent System Cardiovascular 03/11/2022 SPIRIT XLV PAS Ongoing
P110042  S077 BOSTON SCIENTIFIC CORPORATION Model 3501 EMBLEM S-ICD subcutaneous Electrode Cardiovascular 09/29/2017 EMBLEM S-ICD Electrode Model 3501 PAS Ongoing
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
P120006  S031 Endologix, LLC Alto Abdominal Stent Graft System Cardiovascular 03/13/2020 Alto US and OUS Post-Approval Study Ongoing
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 PAS of TS Feat. w Sensor-Augment Pump Sys Redesigned/Replaced Study
P120021 Abbott Medical AMPLATZER PFO OCCLUDER Cardiovascular 10/28/2016 Amplatzer PFO Occluder New Enrollment PAS Progress Adequate
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 Enhanced Safety Surveillance Study Ongoing
P130001 New Day Diagnostics, LLC Epi proColon Pathology 04/12/2016 Epi proColon PAS Hold
P130004 OCULAR THERAPEUTIX, INC. RESURE SEALANT Ophthalmic 01/08/2014 Device Exposure Registry Study Redesigned/Replaced Study
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 New Enrollment Study Ongoing
P130008  S039 INSPIRE MEDICAL SYSTEMS Inspire Upper Airway Stimulation Anesthesiology 04/14/2020 Inspire Pediatric Post-Approval Registry Delayed
P130008  S089 INSPIRE MEDICAL SYSTEMS Inspire Upper Airway Stimulation Anesthesiology 03/20/2023 Inspire UAS New Enrollment PAS Delayed
P130008  S090 INSPIRE MEDICAL SYSTEMS Inspire Upper Airway Stimulation System Anesthesiology 06/08/2023 Inspire UAS High AHI/High BMI PAS Delayed
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 Comprehensive/Linked-Registry Based Surv 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 Ongoing
P130009  S057 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 08/18/2016 Continued f/u of premarket cohort Ongoing
Comprehensive/Linked-Registry Based Surv 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
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 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
P130013  S057 Boston Scientific Corp. WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System Cardiovascular 09/06/2023 SURPASS Pro 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-Tidal Ongoing
P130018 UROMEDICA INC PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN Gastroenterology/
Urology		 11/24/2015 ProAct Post-Approval Study Delayed
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
P130021  S002 Medtronic, Inc. MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 Comprehensive/Linked-Registry Based Surv 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 Progress Adequate
P130021  S025 Medtronic, Inc. Medtronic CoreValve Evolut R XL system Cardiovascular 10/26/2016 Comprehensive/Linked-Registry Based Surv Progress Adequate
P130021  S029 Medtronic, Inc. Medtronic CoreValve Evolut PRO System Cardiovascular 03/20/2017 Comprehensive/Linked-Registry Based Surv 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 Ongoing
Intermediate Risk Surveillance Ongoing
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 Ongoing
Evolut R and PRO Sys Registry-Based Low Risk RWU Ongoing
P130021  S076 Medtronic, Inc. Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System Cardiovascular 08/17/2020 Cont F/u Low Risk Premarket Cohort Ongoing
Low Risk Real World Use Surveillance Ongoing
P130026  S070 St. Jude Medical TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ Cardiovascular 11/04/2021 SE Persistent AF (PsAF) PAS Ongoing
P140003 ABIOMED, INC. IMPELLA 2.5 System Cardiovascular 03/23/2015 New Enrollment Study Redesigned/Replaced Study
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 RW Surveillance of Pts using Sodium Bicarb Study Pending
P140004 Boston Scientific Neuromodulation SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 Superion New Enrollment Study Delayed
P140026  S016 SILK ROAD MEDICAL, INC ENROUTE Transcarotid Stent System Cardiovascular 04/28/2022 ROADSTER 3 PAS Ongoing
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 Ongoing
Comprehensive/Linked-Registry Based Surv Ongoing
P140031  S028 EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/05/2017 SAPIEN 3 Aortic Valve-in-Valve Comp Surv Ongoing
SAPIEN 3 Mitral Valve-in-Valve Comp Surv Ongoing
P140031  S074 EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Cardiovascular 12/27/2018 SAPIEN 3 Ultra Novel Surveillance Ongoing
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 Ongoing
SAPIEN 3 Registry-Based Cont Access & Low Risk RWU Ongoing
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 Ongoing
CAP Cohort and Low Risk Bicuspid RWU Surveillance Ongoing
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 Ongoing
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 Ongoing
P140031  S141 EDWARDS LIFESCIENCES, LLC. Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Cardiovascular 07/28/2022 S3UR Real World Surveillance Ongoing
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 Ongoing
P150002 Cordis US Corporation INCRAFT(R) AAA STENT GRAFT SYSTEM Cardiovascular 11/27/2018 INCRAFT US Post-Approval Study Study Pending
P150003  S039 BOSTON SCIENTIFIC CORPORATION SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Cardiovascular 10/18/2018 EVOLVE 4.5/5.0 Study Ongoing
P150004 Abbott Medical Axium Neurostimulator System Neurology 02/11/2016 F/U Axium Neurostimulator System (FANS) 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 Ongoing
P150005  S035 Boston Scientific Corp. Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters Cardiovascular 08/01/2018 INTERRUPT AF PAS Ongoing
P150005  S049 Boston Scientific Corp. IntellaNav MiFi Open-Irrigated Ablation Catheter Cardiovascular 04/17/2020 DirectSense RF Sub-study Ongoing
P150009 Avertix Medical Inc Guardian System Cardiovascular 04/09/2018 AngelMed Guardian PAS Ongoing
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 PAS of HeartLight Endoscopic Ablation Sys Ongoing
P150026  S002 CARDIOFOCUS, INC. Heart Light Catheter with Excalibur Balloon Cardiovascular 05/02/2018 CF HeartLight PAS Ongoing
P150026  S008 CARDIOFOCUS, INC. HeartLight Endoscopic Ablation System Cardiovascular 05/08/2020 HeartLight X3 PAS Ongoing
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
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
P150030 Smith & Nephew, Inc. R3 DELTA CERAMIC HIP SYSTEM Orthopedic 10/17/2016 Short to Mid-Term f/u of New US Patients Delayed
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 Micra Transcatheter Pacing System PAS Ongoing
P150033  S061 MEDTRONIC Inc. Micra Transcatheter Pacing System, Micra AV Application Software Cardiovascular 01/15/2020 Micra AV Post Approval Study Ongoing
P150033  S166 MEDTRONIC Inc. Micra AV TPS, Micra TPS Cardiovascular 06/07/2023 Micra Jugular Access PAS Ongoing
P150035 Abbott Medical Aveir VR Leadless System Cardiovascular 03/31/2022 The Aveir VR RWE Study Ongoing
P150035  S003 Abbott Medical Aveir DR Leadless System Cardiovascular 06/29/2023 Aveir DR Real-World Evidence Study Ongoing
P150037 Alcon Research, Ltd CyPass Micro-Stent Ophthalmic 07/29/2016 CyPass Micro Stent New Enrollment PAS Hold
COMPASS XXT Post-Approval Study Ongoing
P150038  S006 InSightec ExAblate Neurology 12/16/2018 PAS Registry Study for ExAblate 4000 Delayed
P150038  S014 InSightec Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) Neurology 10/29/2021 ExAblate Neuro PAS Delayed
P150040  S003 Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser Ophthalmic 10/04/2018 VisuMax SMILE New Enrollment Ongoing
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 Ongoing
Model 11500A Prospective PAS Redesigned/Replaced Study
Model 11500A Valve-in-Valve PAS 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 Ongoing
P160001  S020 ReShape Lifesciences, Inc. Obalon Balloon System with Navigation Touch Gastroenterology/
Urology		 12/20/2018 Obalon NTS Post-Approval Study Hold
P160013 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology		 03/22/2018 TOP PAS Registry Ongoing
P160013  S002 TransMedics, Inc Organ Care System (OCS™) Lung System Gastroenterology/
Urology		 05/31/2019 OCS-LUNG-PAS Ongoing
P160015  S001 ZOLL MEDICAL CORPORATION AED 3 defibrillator Cardiovascular 02/28/2020 AED 3 and Pad Placement PAS Ongoing
P160017 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 09/28/2016 MiniMed 670G Post Approval Study Delayed
P160017  S031 MEDTRONIC MINIMED, INC. MiniMed 670G System Clinical Chemistry 06/21/2018 Post-Approval Study Delayed
P160017  S091 MEDTRONIC MINIMED, INC. MiniMed 780G System Clinical Chemistry 04/21/2023 MiniMed 780G New Enrollment Study Ongoing
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 Ongoing
P160030 ABBOTT DIABETES CARE INC. Freestyle Libre Flash Glucose Monitoring System Clinical Chemistry 09/27/2017 FreeStyle Libre Flash Glucose Monitoring Delayed
P160036 DT MedTech LLC Hintermann Series H3 Total Ankle Replacement System Orthopedic 06/04/2019 Hintermann Series H3 TAR Performance Study Ongoing
Hintermann Series H3 TAR Long Term Study Progress Adequate
P160048 Senseonics, Incorporated EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Clinical Chemistry 06/21/2018 Post-Approval Study Ongoing
P160048  S006 Senseonics, Incorporated Eversense Continuous Glucose Monitoring System Clinical Chemistry 06/06/2019 Eversense CGM Non-Adjunctive PAS Ongoing
P160050 INTRINSIC THERAPEUTICS BARRICAID ANULAR CLOSURE DEVICE (ACD) Orthopedic 02/08/2019 Extended F/U-Barricaid ACD Premarket Cohort Delayed
Histological and Retrieval Analysis PAS Ongoing
P160053  S002 ENDOMAGNETICS LTD. MagtraceTM and Sentimag(R) Magnetic Locatization System General &
Plastic Surgery		 12/06/2022 Post-Approval Study (2ml) Study Pending
P160054  S031 Abbott Medical HeartMate 3 Left Ventricular Assist System (HM3 LVAS) Cardiovascular 12/17/2020 Heartmate 3 Real-World Pediatric Use Surveillance Ongoing
P160055 RxSight, Inc. LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) Ophthalmic 11/22/2017 LAL/LDD Postmarket RCT Ongoing
P170002  S026 TEOXANE S.A. RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi General &
Plastic Surgery		 10/13/2023 TEO-PAS-2302 Study Pending
P170002  S030 TEOXANE S.A. RHA®3 dermal filler General &
Plastic Surgery		 10/27/2023 Teoxane Lip Fullness Scale (TLFS) PAS Study Pending
P170003 LUTONIX LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 Cardiovascular 08/25/2017 New Enrollment PAS Registry Ongoing
P170011  S035 Abiomed, Inc. Impella RP System, Impella RP with SmartAssist System Cardiovascular 04/19/2022 Impella RW Surveillance of Pts using Sodium Bicarb 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 Delayed
P170019  S014 Foundation Medicine, Inc. FoundationOne CDx Pathology 06/07/2022 ROZYLTREK PAS Ongoing
P170019  S017 Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 10/23/2020 NTRK Clinical Efficacy PAS for Larotrectinib Ongoing
P170019  S043 Foundation Medicine, Inc. FoundationOne CDx (F1CDx) Pathology 10/06/2023 RET Fusion Clinical Efficacy PAS for Selpercatinib Study Pending
P170027 ZOLL Circulation, 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 Ongoing
P170032 MicroVention, Inc. Woven EndoBridge (WEB) Aneurysm Embolization System Neurology 12/31/2018 PAS1 - PostMarket Surveillance-Long Term Safety Ongoing
P170034 Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC HYDRUS MICROSTENT Ophthalmic 08/10/2018 Modified Hydrus New Enrollment PAS Ongoing
P170036 Spinal Kinetics LLC M6-C Artificial Cervical Disc Orthopedic 02/06/2019 M6-C Artificial Cervical Disc-Extended Follow-up Ongoing
P170038 Abbott CentriMag Circulatory Support System Cardiovascular 12/06/2019 CentriMag FTW PAS Ongoing
P170039 HumanOptics AG CustomFlex Artificial Iris Ophthalmic 05/30/2018 PAS, Adult and Pediatric Delayed
Pediatric New Enrollment Delayed
P170042  S002 C.R. Bard, Inc Covera™ Vascular Covered Stent Cardiovascular 03/01/2019 AVeNEW PAS Ongoing
P170043 Glaukos Corporation iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) Ophthalmic 06/21/2018 Extended f/u Premarket Cohort Delayed
New Enrollment PAS Ongoing
P180001 WILLIAM COOK EUROPE APS Zenith Dissection Endovascular System Cardiovascular 12/31/2018 SVS VQI Postmarket Surveillance Ongoing
P180002 Pulmonx Corporation Zephyr Endobronchial Valve System Anesthesiology 06/29/2018 ZEVR-Zephyr Valve Registry Ongoing
P180002  S005 Pulmonx Corporation Zephyr Endobronchial Valve (EBV) System Anesthesiology 07/30/2019 ZEVR-Zephyr Valve Registry Ongoing
P180007 Gyrus ACMI, Inc. Spiration® Valve System Anesthesiology 12/03/2018 SVS [STRIVE] Post-Market Registry Study Ongoing
P180011 Boston Scientific Corp. Eluvia Drug-Eluting Vascular Stent System Cardiovascular 09/18/2018 REGAL and EMINENT Long Term f/u studies Ongoing
P180014 XVIVO Perfusion, Inc. XPS™ with Steen Solution™ Perfusate Gastroenterology/
Urology		 04/26/2019 NOVEL/NOVEL Ext Cont Long Term PAS Ongoing
Long Term Eval PAS of XPS System Ongoing
P180027  S002 MicroVention, Inc. Flow Re-Direction Endoluminal Device (FRED®) System Neurology 09/16/2021 FRED X PAS Ongoing
P180031 Stryker Neurovascular Neuroform Atlas® Stent System Neurology 05/16/2019 ATLAS Study Ongoing
P180035 CooperVision, Inc. MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Ophthalmic 11/15/2019 MiSight 1 Day PAS Delayed
MiSight 1 Day Safety PAS Delayed
P180036 Impulse Dynamics (USA), Inc. OPTIMIZER Smart System Cardiovascular 03/21/2019 OPTIMIZER Smart System PAS Ongoing
P180050 CVRx, INC. BAROSTIM NEO® System Cardiovascular 08/16/2019 Extended Phase BeAT-HF PAS Ongoing
P180051 TransMedics, Inc. Organ Care System (OCS) Heart System Cardiovascular 09/03/2021 OCS Heart EXPAND+CAP Continued f/u PAS Ongoing
Post-commercialization DBD New Enrollment Study Ongoing
P180051  S001 TransMedics, Inc. OCS Heart System Cardiovascular 04/27/2022 Continued FU of the DCD Heart Premarket Cohort Ongoing
Post-commercialization DCD New Enrollment Study Ongoing
P190008 Medtronic Vascular Inc. IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Cardiovascular 11/21/2019 New Enrollment IN.PACT AV Access PAS Delayed
P190009 Integrum AB OPRA Implant System Orthopedic 12/18/2020 Osseointegration Quality Registry PAS Delayed
TFAOS PAS Ongoing
P190012 Spatz FGIA Inc. Spatz3 Adjustable Balloon System Gastroenterology/
Urology		 10/15/2021 Spatz3 Post-Approval Study Delayed
P190015 Bolton Medical Inc. TREO® Abdominal Stent-Graft System Cardiovascular 05/04/2020 Cont F/u of the IDE Study Subjects Ongoing
TREO Post Approval Study Ongoing
P190019 Boston Scientific Corporation Ranger™ Paclitaxel-Coated PTA Balloon Catheter Cardiovascular 10/30/2020 RANGER II SFA Cont F/u Study Ongoing
P190020 Biosensors International USA, Inc. BioFreedom Drug Coated Coronary Stent System Cardiovascular 04/14/2022 LEADERS FREE II (LFII) Clinical Study Study Pending
P190023 Abbott Medical Portico Transcatheter Aortic Valve Implantation System Cardiovascular 09/17/2021 Cont f/u of the PORTICO IDE cohorts Ongoing
Registry-Based Real World use Surv of the Portico Ongoing
P190023  S002 Abbott Medical Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery System; Navitor Loading System Cardiovascular 01/13/2023 Continued F/U of the IDE Portico NG Study Ongoing
Registry-Based Real-World Use Surveillance Study Ongoing
P190023  S013 Abbott Medical Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery System, Navitor Loading System Cardiovascular 09/15/2023 Cont f/u of the IDE Portico NG Titan Cohort Study Pending
Registry-Based Real-World Use Surv Navitor Titan Study Pending
P200002 AtriCure, Inc. EPi-Sense Guided Coagulation System Cardiovascular 04/28/2021 CONVERGE Post-Approval Study Delayed
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 Ongoing
SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION Ongoing
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 Ongoing
Alterra New Enrollment Study Ongoing
P200020 Lenstec, Inc. SBL-3 Multifocal Intraocular Lens Ophthalmic 07/22/2022 Lenstec SBL-3 PAS Ongoing
P200021 Oticon Medical Neuro Cochlear Implant System Ear Nose & Throat 06/23/2021 New Enrollment Study Hold
P200022  S003 NuVasive, Inc. Simplify Cervical Artificial Disc Orthopedic 04/01/2021 Extended f/u of the 2-Level Simplify Ongoing
P200028 Medtronic Inc. DiamondTemp Ablation System Cardiovascular 01/28/2021 DIAMOND AF PAS Delayed
P200029 Boston Scientific Corporation TheraSphere Radiology 03/17/2021 The Patient Exposure Study Delayed
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 Ongoing
P200031 TransMedics, Inc. Organ Care System (OCS™) Liver Gastroenterology/
Urology		 09/28/2021 OLP New Enrollment PAS Ongoing
P200035 OrganOx Limited OrganOx metra System Gastroenterology/
Urology		 12/09/2021 New Enrollment PAS Ongoing
P200036 Valencia Technologies Corporation eCoin Peripheral Neurostimulator Gastroenterology/
Urology		 03/01/2022 Post-Approval Study of eCoin - RECIPE Delayed
Continued Follow-Up of G170301 Clinical Study Ongoing
P200037 Kestra Medical Technologies, Inc. ASSURE Wearable Cardioverter Defibrillator (WCD) System Cardiovascular 07/27/2021 ACE-PAS Ongoing
P200045 Bolton Medical, Inc. RelayPro Thoracic Stent-Graft System Cardiovascular 08/05/2021 RelayPro Post-Approval Surveillance Study Delayed
Continued f/u of the IDE Study Subjects Ongoing
P200045  S002 Bolton Medical, Inc. RelayPro Thoracic Stent-Graft System Cardiovascular 03/07/2023 Cont f/u Dissection Study Subjects Ongoing
Cont f/u Transection Study Subjects Ongoing
Registry Data Collection for Dissection Ongoing
P200046 Medtronic, Inc. Harmony™ TPV System Cardiovascular 03/26/2021 Continued Follow-up of the Harmony TPV IDE Cohort Ongoing
Harmony TPV New Enrollment Study Ongoing
P200049 Abbott Medical Amplatzer™ Amulet™ Left Atrial Appendage Occluder Cardiovascular 08/14/2021 Continued Follow-up of the Amulet IDE Cohort Ongoing
Amulet Real-World Use Surveillance Ongoing
P210001  S001 Ventana Medical Systems Inc (Roche Tissue Diagnostics) VENTANA MMR RxDx Panel Pathology 03/21/2022 KEYTRUDA PAS Ongoing
P210005 AcuFocus, Inc. IC-8 Apthera Intraocular Lens (IOL) Ophthalmic 07/22/2022 Continuation Study - SAIL-101-PAS Ongoing
New Enrollment Study-IC-8 Apthera IOL Ongoing
P210006 Vascutek Ltd. Thoraflex™ Hybrid Cardiovascular 04/19/2022 EXTEND Post-Approval Study Ongoing
P210015 Avive Solutions, Inc. Avive Automated External Defibrillator (AED) System Cardiovascular 10/31/2022 Avive AED Post-Approval Study Ongoing
P210020 Urotronic, Inc. Optilume Urethral Drug Coated Balloon Gastroenterology/
Urology		 12/03/2021 URINATE PAS (PR1276) Delayed
STREAM PAS (PR1275) Delayed
ROBUST-LT Post-Approval Study (PR1277) Ongoing
P210025 Surmodics, Inc. SurVeil Drug-Coated Balloon Cardiovascular 06/16/2023 TRANSCEND Continued Follow-up Study Ongoing
P210027 Biosense Webster, Inc. QDOT MICRO™ System Cardiovascular 11/23/2022 QDOT MICRO System PAS Ongoing
P210032 W. L. Gore & Associates, Inc. GORE TAG Thoracic Branch Endoprosthesis (TBE Device) Cardiovascular 05/13/2022 Continued Follow-up of the IDE Study Ongoing
Post-Market Surveillance Study Ongoing
P210034 Smith and Nephew, Inc Agili-C Orthopedic 03/29/2022 Extended Follow-up of the Premarket Cohort Ongoing
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 Ongoing
P220002 Premia Spine Ltd. TOPS™ System Orthopedic 06/15/2023 The TOPS System Continued F/U Study Ongoing
P220003 Edwards LifeSciences LLC PASCAL Precision Transcatheter Valve Repair System Cardiovascular 09/14/2022 Continued Follow-up of the CLASP III Trial Cohort Ongoing
Registry-Based Real-World Use Surveillance Study Pending
P220004 Cordis US Corp. PALMAZ MULLINS XD Pulmonary Stent Cardiovascular 07/21/2023 PALMAZ MULLINS XD Real-World Use PAS Study Pending
P220012 Medtronic, Inc. Aurora EV-ICD System Cardiovascular 10/20/2023 Enlighten PAS Study Pending
P220013 Abbott Medical TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency Cable, Ampere™ Radiofrequency Generator, Cool Point Pump Cardiovascular 05/18/2023 TactiFlex SE PAS Protocol Pending
P220014 Pramand, LLC CraniSeal Dural Sealant Neurology 07/06/2023 CraniSeal Registry New Enrollment PAS Delayed
P220021 Endologix, LLC DETOUR System Cardiovascular 06/07/2023 DETOUR2 Continued Follow-up Study Ongoing
PTAB1 New Enrollment Registry Study Ongoing
P220023 ReCor Medical, Inc. Paradise® Ultrasound Renal Denervation System Cardiovascular 11/07/2023 RADIANCE Cont f/u studies-SOLO, TRIO, RADIANCE II Study Pending
(US GPS) New Enrollment Registry Study Study Pending
P220024 Advanced Medical Solutions Limited LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device General &
Plastic Surgery		 06/02/2023 LiquiFix Post-Approval Study Ongoing
P220025 LimFlow, Inc. LimFlow System Cardiovascular 09/11/2023 PROMISE II Continued Follow-up Study Study Pending
PROMISE III Post-Approval Study Study Pending
P220026 Medtronic Inc. Symplicity Spyral™ Renal Denervation System Cardiovascular 11/17/2023 SPYRAL HTN-OFF MED and HTN-ON MED Cont f/u studies Ongoing
SPYRAL AFFIRM PAS: New Enrollment Registry Study Study Pending
P220029 Urotronic, Inc Optilume™ BPH Catheter System Gastroenterology/
Urology		 06/30/2023 PEAK PAS Ongoing
PINNACLE Study Study Pending
P220032 Boston Scientific Corporation POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories Cardiovascular 08/08/2023 POLARx PAS Study Pending
P230002 MicroCube, LLC Minitouch 3.8 Era System (Minitouch System) Obstetrics/
Gynecology		 07/28/2023 EASE Clinical Trial Ongoing
P230007 Abbott Medical TriClip G4 System Cardiovascular 04/01/2024 Registry-Based Real-World Use Surveillance Protocol Pending
Contuned f/u of the Premarket Cohort Study Pending
P230013 Edwards Lifesciences LLC Edwards EVOQUE Tricuspid Valve Replacement System Cardiovascular 02/01/2024 Registry-Based Real-World Use Surveillance Study Pending
P230017 Medtronic, Inc. PulseSelect™ Pulsed Field Ablation (PFA) system Cardiovascular 12/13/2023 PULSED AF Post Approval Study Protocol Pending
P230021 Vesper Medical, Inc. Duo Venous Stent System Cardiovascular 12/26/2023 VIVID Continued Follow-up Study Study Pending
P230023 W.L. Gore & Associates, Inc. GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Cardiovascular 01/12/2024 Continued Follow-up of the IDE Study Subjects Study Pending
GORE TAMBE Post-Approval Study Study Pending
P230030 FARAPULSE, Inc. FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, FARASTAR™ Pulsed Field Ablation Generator, FARASTAR™ Recording System Module, FARASTAR™ Stimulation Module Cable, FARASTAR™ EGM Cable, FARASTAR™ Stimulation Module Male Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Y-Cable Long, FARASTAR™ Stimulation Module Y-Cable Short, FARASTAR™ Recording System Module Catheter Pin Cable, FARASTAR™ Recording System Module ECG Trunk Cable (AAMI/IEC), FARASTAR™ Recording System Module ECG Output Cable (AAMI/IEC), FARASTAR™ Recording System Module EGM Input Module, FARASTAR™ SNAP CABLE R/L – (AAMI/IEC), FARASTAR™ SNAP CABLE V SET – (AAMI/IEC)) Cardiovascular 01/30/2024 ADVENT Post-Approval Study Protocol Pending
P230032 AutoGenomics, Inc. AvertD and AvertD Buccal Sample Collection Kit Toxicology 12/19/2023 AvertD Post-Approval Study Study Pending
P230035 Boston Scientific Corporation AGENT Paclitaxel-Coated Balloon Catheter Cardiovascular 02/29/2024 AGENT Post-Approval Surveillance Analysis Protocol Pending
AGENT IDE Continued Follow-up Study Study Pending
P810002  S101 Abbott Medical SJM Masters Series Mechanical Heart Valve, 15mm HP Cardiovascular 03/06/2018 HALO PAS Ongoing
P860057  S029 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term Ongoing
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 Ongoing
P910073  S145 BOSTON SCIENTIFIC Reliance 4- Front Lead Family and Suture Sleeve Accessory Cardiovascular 05/04/2018 MOUNTAIN PAS Ongoing
P930016  S053 AMO Manufacturing USA, LLC iDESIGNRefractive Studio, STAR Excimer Laser System Ophthalmic 06/15/2018 STAR-122-MVPM Post-Approval Study Delayed
P960009  S219 MEDTRONIC Inc. MEDTRONIC DBS THERAPY FOR EPILEPSY Neurology 04/27/2018 DBS for Epilepsy New Enrollment PAS Delayed
P960013  S122 Abbott Medical Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads Cardiovascular 05/11/2023 UltiPace Lead RWE Study Ongoing
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
P970051  S205 Cochlear Americas Nucleus 24 Cochlear Implant System Ear Nose & Throat 01/10/2022 Cochlear New Enrollment SSD/UHL Study 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
P980023  S113 BIOTRONIK, INC. Pamira ICD Leads Cardiovascular 01/20/2023 Pamira EP PASSION PAS Ongoing


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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