|
|
Application Number |
|
|
|
Applicant |
|
|
|
Device Name |
|
|
|
Medical Specialty |
|
|
|
Date PMA Approved |
|
|
|
|
P170038
|
Abbott |
CentriMag Circulatory Support System |
Cardiovascular |
12/06/2019 |
CentriMag FTW PAS
|
Ongoing |
P160030
|
ABBOTT DIABETES CARE INC. |
Freestyle Libre Flash Glucose Monitoring System |
Clinical Chemistry |
09/27/2017 |
FreeStyle Libre Flash Glucose Monitoring
|
Delayed |
P040040
|
Abbott Medical |
AMPLATZER MUSCULAR VSD OCCLUDER |
Cardiovascular |
09/07/2007 |
Post Approval Study
|
Ongoing |
P100009
|
Abbott Medical |
MITRACLIP DELIVERY SYSTEM |
Cardiovascular |
10/24/2013 |
Comprehensive/Linked-Registry Based Surv
|
Progress Adequate |
P120021
|
Abbott Medical |
AMPLATZER PFO OCCLUDER |
Cardiovascular |
10/28/2016 |
Amplatzer PFO Occluder New Enrollment PAS
|
Progress Adequate |
P150004
|
Abbott Medical |
Axium Neurostimulator System |
Neurology |
02/11/2016 |
F/U Axium Neurostimulator System (FANS)
|
Progress Adequate |
P150035
|
Abbott Medical |
Aveir VR Leadless System |
Cardiovascular |
03/31/2022 |
The Aveir VR RWE Study
|
Ongoing |
P810002
S101
|
Abbott Medical |
SJM Masters Series Mechanical Heart Valve, 15mm HP |
Cardiovascular |
03/06/2018 |
HALO PAS
|
Ongoing |
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 |
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 |
P160054
S031
|
Abbott Medical |
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) |
Cardiovascular |
12/17/2020 |
Heartmate 3 Real-World Pediatric Use Surveillance
|
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 |
P100045
S056
|
Abbott Medical |
CardioMEMs HF System |
Cardiovascular |
02/18/2022 |
CMEMS RWE PAS
|
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 |
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 |
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
|
Study Pending |
P960013
S122
|
Abbott Medical |
Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads |
Cardiovascular |
05/11/2023 |
UltiPace Lead RWE Study
|
Ongoing |
P150035
S003
|
Abbott Medical |
Aveir DR Leadless System |
Cardiovascular |
06/29/2023 |
Aveir DR Real-World Evidence Study
|
Ongoing |
P230007
|
Abbott Medical |
TriClip G4 System |
Cardiovascular |
04/01/2024 |
Contuned f/u of the Premarket Cohort
|
Study Pending |
Registry-Based Real-World Use Surveillance
|
Study Pending |
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 |
Registry-Based Real-World Use Surv Navitor Titan
|
Ongoing |
Cont f/u of the IDE Portico NG Titan Cohort
|
Study Pending |
P230036
|
Abbott Medical |
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Cardiovascular |
04/26/2024 |
LIFE-BTK RCT Continued Follow-up Study
|
Study Pending |
Esprit BTK-PAS - New Enrollment Study
|
Study Pending |
P110019
S118
|
ABBOTT VASCULAR |
XIENCE Skypoint Everolimus Eluting Coronary Stent System |
Cardiovascular |
03/11/2022 |
SPIRIT XLV 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 |
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 |
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 |
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 |
P120024
|
AESCULAP IMPLANT SYSTEMS, LLC |
ACTIVL ARTIFICIAL DISC |
Orthopedic |
06/11/2015 |
Enhanced Safety Surveillance Study
|
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 |
P040046
|
Allergan |
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS |
General & Plastic Surgery |
02/20/2013 |
Natrelle and 410 Combined Cohort
|
Ongoing |
P930016
S053
|
AMO Manufacturing USA, LLC |
iDESIGNRefractive Studio, STAR Excimer Laser System |
Ophthalmic |
06/15/2018 |
STAR-122-MVPM Post-Approval Study
|
Delayed |
H170001
|
ApiFix, Ltd. |
Minimally Invasive Deformity Correction (MID-C) System |
Orthopedic |
08/23/2019 |
MID-C System Registry PAS
|
Delayed |
P200002
|
AtriCure, Inc. |
EPi-Sense Guided Coagulation System |
Cardiovascular |
04/28/2021 |
CONVERGE Post-Approval Study
|
Delayed |
P230032
|
AutoGenomics, Inc. |
AvertD and AvertD Buccal Sample Collection Kit |
Toxicology |
12/19/2023 |
AvertD Post-Approval Study
|
Study Pending |
P150009
|
Avertix Medical Inc |
Guardian System |
Cardiovascular |
04/09/2018 |
AngelMed Guardian PAS
|
Ongoing |
P210015
|
Avive Solutions, Inc. |
Avive Automated External Defibrillator (AED) System |
Cardiovascular |
10/31/2022 |
Avive AED Post-Approval Study
|
Ongoing |
P160037
S017
|
BECTON, DICKINSON AND COMPANY |
BD Onclarity HPV Assay |
Microbiology |
05/14/2024 |
SHIP-Sub-Protocol LMI-001-A-S01
|
Study Pending |
P100006
S005
|
BIOMIMETIC THERAPEUTICS,LLC |
AUGMENT INJECTABLE |
Orthopedic |
06/12/2018 |
Long-term PAS
|
Delayed |
P030031
S100
|
BIOSENSE WEBSTER, INC. |
THERMOCOOL SMARTTOUCH® SF Catheter |
Cardiovascular |
09/30/2020 |
Real-World Experience of Catheter Ablation of PsAF
|
Ongoing |
P210027
|
Biosense Webster, Inc. |
QDOT MICRO™ System |
Cardiovascular |
11/23/2022 |
QDOT MICRO System PAS
|
Ongoing |
P190020
|
Biosensors International USA, Inc. |
BioFreedom Drug Coated Coronary Stent System |
Cardiovascular |
04/14/2022 |
LEADERS FREE II (LFII) Clinical Study
|
Study Pending |
P170030
|
Biotronik, Inc |
ORSIRO Sirolimus Eluting Coronary Stent System |
Cardiovascular |
02/22/2019 |
Bioflow-VII New Enrollment PAS
|
Ongoing |
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 |
P980023
S113
|
BIOTRONIK, INC. |
Pamira ICD Leads |
Cardiovascular |
01/20/2023 |
Pamira EP PASSION PAS
|
Ongoing |
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 |
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 |
P910073
S145
|
BOSTON SCIENTIFIC |
Reliance 4- Front Lead Family and Suture Sleeve Accessory |
Cardiovascular |
05/04/2018 |
MOUNTAIN PAS
|
Ongoing |
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 |
P130013
|
Boston Scientific Corp. |
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY |
Cardiovascular |
03/13/2015 |
WATCHMAN New Enrollment (NESTed-PAS)
|
Redesigned/Replaced Study |
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 |
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 |
P110042
S077
|
BOSTON SCIENTIFIC CORPORATION |
Model 3501 EMBLEM S-ICD subcutaneous Electrode |
Cardiovascular |
09/29/2017 |
EMBLEM S-ICD Electrode Model 3501 PAS
|
Ongoing |
P150003
S039
|
BOSTON SCIENTIFIC CORPORATION |
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System |
Cardiovascular |
10/18/2018 |
EVOLVE 4.5/5.0 Study
|
Ongoing |
P220032
|
Boston Scientific Corporation |
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories |
Cardiovascular |
08/08/2023 |
POLARx PAS
|
Ongoing |
P230035
|
Boston Scientific Corporation |
AGENT Paclitaxel-Coated Balloon Catheter |
Cardiovascular |
02/29/2024 |
AGENT Post-Approval Surveillance Analysis
|
Study Pending |
AGENT IDE Continued Follow-up Study
|
Study Pending |
P140004
|
Boston Scientific Neuromodulation |
SUPERION INTERSPINOUS SPACER |
Orthopedic |
05/20/2015 |
Superion New Enrollment Study
|
Delayed |
P170042
S002
|
C.R. Bard, Inc |
Covera™ Vascular Covered Stent |
Cardiovascular |
03/01/2019 |
AVeNEW 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 |
P150040
S003
|
Carl Zeiss Meditec, Inc. |
VisuMax Femtosecond Laser |
Ophthalmic |
10/04/2018 |
VisuMax SMILE New Enrollment
|
Ongoing |
P970051
S205
|
Cochlear Americas |
Nucleus 24 Cochlear Implant System |
Ear Nose & Throat |
01/10/2022 |
Cochlear New Enrollment SSD/UHL 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 |
P220004
|
Cordis US Corp. |
PALMAZ MULLINS XD Pulmonary Stent |
Cardiovascular |
07/21/2023 |
PALMAZ MULLINS XD Real-World Use PAS
|
Study Pending |
P150002
|
Cordis US Corporation |
INCRAFT(R) AAA STENT GRAFT SYSTEM |
Cardiovascular |
11/27/2018 |
INCRAFT US Post-Approval Study
|
Study Pending |
P040023
|
DEPUY ORTHOPAEDICS, INC. |
DURALOC OPTION CERAMIC HIP SYSTEM |
Orthopedic |
05/03/2005 |
Duraloc Long Term
|
Redesigned/Replaced Study |
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 |
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 |
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
|
Ongoing |
P160036
|
DT MedTech LLC |
Hintermann Series H3 Total Ankle Replacement System |
Orthopedic |
06/04/2019 |
Hintermann Series H3 TAR Long Term Study
|
Ongoing |
Hintermann Series H3 TAR Performance 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
|
Ongoing |
P230013
|
Edwards Lifesciences LLC |
Edwards EVOQUE Tricuspid Valve Replacement System |
Cardiovascular |
02/01/2024 |
Registry-Based Real-World Use Surveillance
|
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
|
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 |
P860057
S029
|
EDWARDS LIFESCIENCES, LLC. |
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX |
Cardiovascular |
08/29/2008 |
Long Term
|
Ongoing |
P130009
|
EDWARDS LIFESCIENCES, LLC. |
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
06/16/2014 |
Comprehensive/Linked-Registry Based Surv
|
Progress Adequate |
P140031
|
EDWARDS LIFESCIENCES, LLC. |
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
06/17/2015 |
Comprehensive/Linked-Registry
|
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 |
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 |
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 |
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
|
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 |
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 |
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 |
P140031
S162
|
EDWARDS LIFESCIENCES, LLC. |
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems |
Cardiovascular |
05/23/2024 |
Intermediate Risk Indication Real-World Use Surv
|
Study Pending |
P120006
S031
|
Endologix, LLC |
Alto Abdominal Stent Graft System |
Cardiovascular |
03/13/2020 |
Alto US and OUS Post-Approval Study
|
Ongoing |
P040002
S070
|
Endologix, LLC |
AFX2 Endovascular AAA System |
Cardiovascular |
12/06/2022 |
VQI and VISION EVAR Registry Analysis
|
Ongoing |
P220021
|
Endologix, LLC |
DETOUR System |
Cardiovascular |
06/07/2023 |
DETOUR2 Continued Follow-up Study
|
Ongoing |
PTAB1 New Enrollment Registry Study
|
Ongoing |
P160053
S002
|
ENDOMAGNETICS LTD. |
MagtraceTM and Sentimag(R) Magnetic Locatization System |
General & Plastic Surgery |
12/06/2022 |
Post-Approval Study (2ml)
|
Hold |
P160053
S009
|
ENDOMAGNETICS LTD. |
Magtrace and Sentimag Magnetic Localization System |
General & Plastic Surgery |
04/15/2024 |
1ml Magtrace w Sentimag PAS
|
Study Pending |
P230040
|
Endotronix, Inc. |
Cordella Pulmonary Artery Sensor System (CorPASS) |
Cardiovascular |
06/20/2024 |
PROACTIVE-HF Study
|
Protocol Pending |
P090018
|
ENVOY MEDICAL CORPORATION |
ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM |
Ear Nose & Throat |
03/17/2010 |
New Enrollment
|
Redesigned/Replaced Study |
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 |
P050039
|
EXACTECH, INC. |
NOVATION CERAMIC ARTICULATION HIP SYSTEM |
Orthopedic |
07/05/2007 |
Long Term
|
Redesigned/Replaced Study |
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
|
Study Pending |
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
|
Ongoing |
P230001
|
Geneoscopy, Inc. |
ColoSense® |
Pathology |
05/03/2024 |
ColoSense Post-Approval Study
|
Study Pending |
P170043
|
Glaukos Corporation |
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) |
Ophthalmic |
06/21/2018 |
Extended f/u Premarket Cohort
|
Ongoing |
New Enrollment PAS
|
Ongoing |
P080030
|
GLAUKOS, CORPORATION |
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L |
Ophthalmic |
06/25/2012 |
Registry Study
|
Redesigned/Replaced Study |
H210002
|
Globus Medical, Inc. |
REFLECT™ Scoliosis Correction System |
Orthopedic |
05/15/2023 |
REFLECT Scoliosis Correction System Registry PAS
|
Delayed |
P230026
|
Goodman Co., Ltd. |
Lacrosse NSE ALPHA Coronary Dilatation Catheter |
Cardiovascular |
06/06/2024 |
NSA Alpha New Enrollment PAS
|
Study Pending |
P230009
|
Guardant Health, Inc. |
Shield |
Molecular Genetics |
07/26/2024 |
Shield Post-Approval Study
|
Protocol Pending |
P180007
|
Gyrus ACMI, Inc. |
Spiration® Valve System |
Anesthesiology |
12/03/2018 |
SVS [STRIVE] Post-Market Registry Study
|
Ongoing |
H190001
|
HDL Therapeutics, Inc. |
Plasma Delipidation System (PDS-2™ System) |
Gastroenterology/ Urology |
12/01/2020 |
HALO-FHII PAS
|
Hold |
HF PAS
|
Hold |
P170039
|
HumanOptics AG |
CustomFlex Artificial Iris |
Ophthalmic |
05/30/2018 |
PAS, Adult and Pediatric
|
Delayed |
Pediatric New Enrollment
|
Delayed |
P180036
|
Impulse Dynamics (USA), Inc. |
OPTIMIZER Smart System |
Cardiovascular |
03/21/2019 |
OPTIMIZER Smart System PAS
|
Ongoing |
P080012
|
Infusyn Therapeutics, LLC |
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM |
General Hospital |
02/07/2012 |
Extended Use Stability Study
|
Hold |
Prometra Programmable Pump System
|
Ongoing |
Leachables 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 |
P040003
S015
|
INSIGHTEC, LTD |
EXABLATE |
Obstetrics/ Gynecology |
08/31/2015 |
Post ExAblate Pregnancy Outcomes Registry
|
Delayed |
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 |
P190009
|
Integrum AB |
OPRA Implant System |
Orthopedic |
12/18/2020 |
Osseointegration Quality Registry PAS
|
Delayed |
TFAOS 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 |
P170034
|
Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC |
HYDRUS MICROSTENT |
Ophthalmic |
08/10/2018 |
Modified Hydrus New Enrollment PAS
|
Ongoing |
H130001
|
KANEKA PHARMA AMERICA LLC |
KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN |
Gastroenterology/ Urology |
03/05/2015 |
New Enrollment Study
|
Delayed |
H120005
|
KANEKA PHARMA AMERICA LLC |
LIPOSORBER LA-15 SYSTEM |
Gastroenterology/ Urology |
10/10/2013 |
New Enroll. PAS for Liposorber LA-15 Sys
|
Delayed |
H170002
|
Kaneka Pharma America LLC |
LIPOSORBER LA-15 System |
Gastroenterology/ Urology |
03/20/2018 |
New Enroll PAS LIPOSORBER LA-15 Adults
|
Delayed |
P200037
|
Kestra Medical Technologies, Inc. |
ASSURE Wearable Cardioverter Defibrillator (WCD) System |
Cardiovascular |
07/27/2021 |
ACE-PAS
|
Ongoing |
P200020
|
Lenstec, Inc. |
SBL-3 Multifocal Intraocular Lens |
Ophthalmic |
07/22/2022 |
Lenstec SBL-3 PAS
|
Ongoing |
P220025
|
LimFlow, Inc. |
LimFlow System |
Cardiovascular |
09/11/2023 |
PROMISE III Post-Approval Study
|
Ongoing |
PROMISE II Continued Follow-up Study
|
Study Pending |
P170003
|
LUTONIX |
LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 |
Cardiovascular |
08/25/2017 |
New Enrollment PAS Registry
|
Ongoing |
P000025
S104
|
MED-EL CORP. |
MED-EL Cochlear Implant System |
Ear Nose & Throat |
07/19/2019 |
MED-EL New Enrollment SSD/AHL Study
|
Ongoing |
P100047
S090
|
Medtronic |
HeartWare™ HVAD™ System |
Cardiovascular |
09/27/2017 |
ENDURANCE 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 |
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 |
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 |
P120010
|
MEDTRONIC Inc. |
MINIMED 530G SYSTEM |
Clinical Chemistry |
09/26/2013 |
PAS of TS Feat. w Sensor-Augment Pump Sys
|
Redesigned/Replaced Study |
P960009
S219
|
MEDTRONIC Inc. |
MEDTRONIC DBS THERAPY FOR EPILEPSY |
Neurology |
04/27/2018 |
DBS for Epilepsy New Enrollment PAS
|
Delayed |
P150033
|
MEDTRONIC Inc. |
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
Cardiovascular |
04/06/2016 |
Micra Transcatheter Pacing System PAS
|
Ongoing |
P080006
S129
|
MEDTRONIC Inc. |
Attain Stability Quad MRI SureScan Lead |
Cardiovascular |
04/10/2019 |
Attain Stability Quad PAS
|
Ongoing |
P150033
S061
|
MEDTRONIC Inc. |
Micra Transcatheter Pacing System, Micra AV Application Software |
Cardiovascular |
01/15/2020 |
Micra AV Post Approval Study
|
Ongoing |
P200028
|
Medtronic Inc. |
DiamondTemp Ablation System |
Cardiovascular |
01/28/2021 |
DIAMOND AF PAS
|
Delayed |
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
|
Ongoing |
P150033
S166
|
MEDTRONIC Inc. |
Micra AV TPS, Micra TPS |
Cardiovascular |
06/07/2023 |
Micra Jugular Access 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 |
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 |
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 |
P100021
S063
|
Medtronic Vascular |
Endurant II/IIs Stent Graft System |
Cardiovascular |
09/29/2017 |
Cont f/u ANCHOR Reg Short Neck Cohort
|
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 |
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 |
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 |
P130021
S025
|
Medtronic, Inc. |
Medtronic CoreValve Evolut R XL system |
Cardiovascular |
10/26/2016 |
Comprehensive/Linked-Registry Based Surv
|
Progress Adequate |
P890003
S372
|
Medtronic, Inc. |
SYNERGYST II PULSE GENERATOR |
Cardiovascular |
09/01/2017 |
Heart Failure Risk Status (HFRS) PAS
|
Ongoing |
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 |
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 |
P220012
|
Medtronic, Inc. |
Aurora EV-ICD System |
Cardiovascular |
10/20/2023 |
Enlighten PAS
|
Ongoing |
P230017
|
Medtronic, Inc. |
PulseSelect™ Pulsed Field Ablation (PFA) system |
Cardiovascular |
12/13/2023 |
PULSED AF Post Approval Study
|
Study Pending |
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 |
P060028
|
MENTOR WORLDWIDE LLC |
MENTOR MEMORYSHAPE BREAST IMPLANTS |
General & Plastic Surgery |
06/14/2013 |
MemoryGel and Shape Glow Study
|
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
|
Delayed |
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
|
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 |
P170032
|
MicroVention, Inc. |
Woven EndoBridge (WEB) Aneurysm Embolization System |
Neurology |
12/31/2018 |
PAS1 - PostMarket Surveillance-Long Term Safety
|
Ongoing |
P180027
S002
|
MicroVention, Inc. |
Flow Re-Direction Endoluminal Device (FRED®) System |
Neurology |
09/16/2021 |
FRED X PAS
|
Ongoing |
P100026
|
NEUROPACE INC |
NEUROPACE RNS SYSTEM |
Neurology |
11/14/2013 |
New Enrollment - All Comers
|
Delayed |
New Enrollment -Performance & Programming
|
Delayed |
P130001
|
New Day Diagnostics, LLC |
Epi proColon |
Pathology |
04/12/2016 |
Epi proColon PAS
|
Hold |
P100034
|
Novocure GmbH |
NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
Neurology |
04/08/2011 |
New Enrollment Study for NovoTTF-100A
|
Redesigned/Replaced Study |
P150028
|
NUMED, INC. |
CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) |
Cardiovascular |
03/25/2016 |
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 |
P200022
S003
|
NuVasive, Inc. |
Simplify Cervical Artificial Disc |
Orthopedic |
04/01/2021 |
Extended f/u of the 2-Level Simplify
|
Ongoing |
P130004
|
OCULAR THERAPEUTIX, INC. |
RESURE SEALANT |
Ophthalmic |
01/08/2014 |
Device Exposure Registry Study
|
Redesigned/Replaced Study |
P000037
S030
|
On-X Life Technologies, Inc. |
ON-X PROSTHETIC HEART VALVE |
Cardiovascular |
04/01/2015 |
Newly Enrolled On-X PAS
|
Ongoing |
P200035
|
OrganOx Limited |
OrganOx metra System |
Gastroenterology/ Urology |
12/09/2021 |
New Enrollment PAS
|
Ongoing |
H200001
|
Paragon 28, Inc. |
Patient Specific Talus Spacer |
Orthopedic |
02/17/2021 |
Patient Specific Talus Spacer PAS
|
Delayed |
P220014
|
Pramand, LLC |
CraniSeal Dural Sealant |
Neurology |
07/06/2023 |
CraniSeal Registry New Enrollment PAS
|
Delayed |
P220002
|
Premia Spine Ltd. |
TOPS™ System |
Orthopedic |
06/15/2023 |
The TOPS System Continued F/U Study
|
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 |
H090002
|
PYREXAR MEDICAL INC |
BSD-2000 HYPERTHERMIA SYSTEM |
Obstetrics/ Gynecology |
11/18/2011 |
Deep Hyperthermia and Radiation
|
Redesigned/Replaced Study |
P220023
|
ReCor Medical, Inc. |
Paradise® Ultrasound Renal Denervation System |
Cardiovascular |
11/07/2023 |
RADIANCE Cont f/u studies-SOLO, TRIO, RADIANCE II
|
Ongoing |
(US GPS) New Enrollment Registry Study
|
Ongoing |
P000008
|
ReShape Lifesciences, Inc. |
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM |
Gastroenterology/ Urology |
06/05/2001 |
Lap-Band Long Term
|
Redesigned/Replaced Study |
P160001
S020
|
ReShape Lifesciences, Inc. |
Obalon Balloon System with Navigation Touch |
Gastroenterology/ Urology |
12/20/2018 |
Obalon NTS Post-Approval Study
|
Hold |
H230003
|
restor3d, Inc. |
restor3d Total Talus Replacement |
Orthopedic |
11/17/2023 |
Total Talus Replacement (TTR) PAS
|
Ongoing |
P100020
S055
|
Roche Molecular Systems, Inc. |
cobas HPV Test |
Microbiology |
05/14/2024 |
SHIP-Sub-Protocol LMI-001-A-S02
|
Study Pending |
P190028
S009
|
Roche Molecular Systems, Inc. |
cobas HPV |
Microbiology |
05/14/2024 |
SHIP Sub-Protocol LMI-001-A-S03
|
Study Pending |
P160055
|
RxSight, Inc. |
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) |
Ophthalmic |
11/22/2017 |
LAL/LDD Postmarket RCT
|
Ongoing |
P050034
|
Samsara Vision Inc. |
IMPLANTABLE MINIATURE TELESCOPE (IMT) |
Ophthalmic |
07/01/2010 |
IMT PAS 01 New Enrollment Study
|
Delayed |
P160048
S006
|
Senseonics, Incorporated |
Eversense Continuous Glucose Monitoring System |
Clinical Chemistry |
06/06/2019 |
Eversense CGM Non-Adjunctive PAS
|
Ongoing |
P070004
|
SIENTRA, INC |
SIENTRA SILICONE GEL BREAST IMPLANTS |
General & Plastic Surgery |
03/09/2012 |
US Post-Approval Study (US-PAS)
|
Delayed |
P140026
S016
|
SILK ROAD MEDICAL, INC |
ENROUTE Transcarotid Stent System |
Cardiovascular |
04/28/2022 |
ROADSTER 3 PAS
|
Delayed |
P040033
|
Smith & Nephew, Inc. |
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM |
Orthopedic |
05/09/2006 |
US Study
|
Ongoing |
P150030
|
Smith & Nephew, Inc. |
R3 DELTA CERAMIC HIP SYSTEM |
Orthopedic |
10/17/2016 |
Short to Mid-Term f/u of New US Patients
|
Delayed |
P210034
|
Smith and Nephew, Inc |
Agili-C |
Orthopedic |
03/29/2022 |
Extended Follow-up of the Premarket Cohort
|
Ongoing |
P190012
|
Spatz FGIA Inc. |
Spatz3 Adjustable Balloon System |
Gastroenterology/ Urology |
10/15/2021 |
Spatz3 Post-Approval Study
|
Delayed |
P170036
|
Spinal Kinetics LLC |
M6-C Artificial Cervical Disc |
Orthopedic |
02/06/2019 |
M6-C Artificial Cervical Disc-Extended Follow-up
|
Ongoing |
P130026
S070
|
St. Jude Medical |
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ |
Cardiovascular |
11/04/2021 |
SE Persistent AF (PsAF) PAS
|
Ongoing |
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 |
P040051
|
STELKAST COMPANY |
STELKAST SURPASS ACETABULAR SYSTEM |
Orthopedic |
05/12/2006 |
Long term
|
Redesigned/Replaced Study |
P180031
|
Stryker Neurovascular |
Neuroform Atlas® Stent System |
Neurology |
05/16/2019 |
ATLAS Study
|
Ongoing |
P210025
|
Surmodics, Inc. |
SurVeil Drug-Coated Balloon |
Cardiovascular |
06/16/2023 |
TRANSCEND Continued Follow-up Study
|
Ongoing |
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 |
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
|
Ongoing |
P170002
S030
|
TEOXANE S.A. |
RHA®3 dermal filler |
General & Plastic Surgery |
10/27/2023 |
Teoxane Lip Fullness Scale (TLFS) PAS
|
Ongoing |
H220001
|
TheraBionic, Inc. |
TheraBionic P1 |
General & Plastic Surgery |
09/26/2023 |
The TheraBionic P1 Post-Approval Study
|
Study Pending |
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 |
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 |
P200031
|
TransMedics, Inc. |
Organ Care System (OCS™) Liver |
Gastroenterology/ Urology |
09/28/2021 |
OLP New Enrollment PAS
|
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 |
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 |
P130018
|
UROMEDICA INC |
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN |
Gastroenterology/ Urology |
11/24/2015 |
ProAct Post-Approval Study
|
Delayed |
P220029
|
Urotronic, Inc |
Optilume™ BPH Catheter System |
Gastroenterology/ Urology |
06/30/2023 |
PINNACLE Study
|
Ongoing |
PEAK PAS
|
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 |
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 |
P210006
|
Vascutek Ltd. |
Thoraflex™ Hybrid |
Cardiovascular |
04/19/2022 |
EXTEND Post-Approval Study
|
Ongoing |
P230021
|
Vesper Medical, Inc. |
Duo Venous Stent System |
Cardiovascular |
12/26/2023 |
VIVID Continued Follow-up Study
|
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 |
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 |
P200030
S014
|
W. L. Gore and Associates, Inc. |
GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) |
Cardiovascular |
04/05/2024 |
PostApproval Surveillance - Gore Together Registry
|
Protocol Pending |
Continued Follow-up of the IDE Study Subjects
|
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 |
P050006
S060
|
W.L. GORE & ASSOCIATES,INC |
GORE CARDIOFORM Septal Occluder |
Cardiovascular |
03/30/2018 |
GORE CARDIOFORM New Enrollment PAS
|
Ongoing |
P180001
|
WILLIAM COOK EUROPE APS |
Zenith Dissection Endovascular System |
Cardiovascular |
12/31/2018 |
SVS VQI Postmarket Surveillance
|
Ongoing |
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 |
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 |
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 |
P110002
|
Zimmer Biomet Spine, Inc. |
MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) |
Orthopedic |
08/07/2013 |
Enhanced Surveillance System
|
Ongoing |
Retrieval Analysis
|
Ongoing |
P110009
|
Zimmer Biomet Spine, Inc. |
MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) |
Orthopedic |
08/23/2013 |
Retrieval Analysis
|
Ongoing |
H190005
|
Zimmer Biomet Spine, Inc. |
The Tether™ - Vertebral Body Tethering System |
Orthopedic |
08/16/2019 |
The Tether Vertebral Tethering System PAS
|
Ongoing |
P040048
|
ZIMMER, INC. |
TRILOGY AB ACETABULAR SYSTEM |
Orthopedic |
06/28/2006 |
Long term
|
Redesigned/Replaced Study |
P170027
|
ZOLL Circulation, Inc. |
TherOx Downstream System |
Cardiovascular |
04/02/2019 |
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 |
P160015
S001
|
ZOLL MEDICAL CORPORATION |
AED 3 defibrillator |
Cardiovascular |
02/28/2020 |
AED 3 and Pad Placement PAS
|
Ongoing |