PMA approvals
Premarket approvals for Class III devices and their supplements: trade name, applicant and decision. 57,487 records; openFDA updated it 2026-11-09. About this dataset
Newest records
- APPR28,630
- OK3028,082
- APWD403
- APRL355
- APCB11
- APCV6
- Liverty TIPS Stent GraftFDA page
Bard Peripheral Vascular, Inc. · SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS · Cardiovascular
- Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena QuadripolarFDA page
Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT) · Cardiovascular
- Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, RiFDA page
Biotronik, Inc. · Implantable cardioverter defibrillator (non-CRT) · Cardiovascular
- PASCAL Precision Transcatheter Valve Repair SystemFDA page
Edwards Lifesciences, LLC · Mitral valve repair devices · Cardiovascular
- INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral ValveFDA page
Edwards Lifesciences, LLC · heart-valve, non-allograft tissue · Cardiovascular
- Model 3150 IPGFDA page
Inspire Medical Systems · Stimulator, hypoglossal nerve, implanted, apnea · Anesthesiology
- Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8FDA page
Biotronik, Inc. · implantable pacemaker Pulse-generator · Cardiovascular
- RxSight Light Adjustable Lens and Light Delivery DeviceFDA page
Rxsight, Inc. · Light adjustable lens (LAL) and light delivery device (LDD) · Ophthalmic
- Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor AurFDA page
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
- Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT, Inlexa 7 VRTFDA page
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
- Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart ValveFDA page
Edwards Lifesciences, LLC · Aortic valve, prosthesis, percutaneously delivered · Cardiovascular
- Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMRFDA page
Biotronik, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) · Cardiovascular
- ROTAPRO Rotational Atherectomy SystemFDA page
Boston Scientific Corp · CATHETER, CORONARY, ATHERECTOMY · Cardiovascular
- EVOQUE Tricuspid Valve Replacement SystemFDA page
Edwards Lifesciences, LLC · Percutaneously Delivered Prostheses and Tricuspid Valves · Cardiovascular
- ROTAPRO Rotational Atherectomy SystemsFDA page
Boston Scientific Corp · CATHETER, CORONARY, ATHERECTOMY · Cardiovascular
- MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESFDA page
Mentor Worldwide, LLC · Prosthesis, breast, inflatable, internal, saline · General, Plastic Surgery
- Embrace(TM) Hydrogel Embolic SystemFDA page
Instylla, Inc. · Embolization Agent, Vascular · Cardiovascular
- Belotero Intense (+) Lidocaine Dermal FillerFDA page
Merz North America, Inc. · Implant, dermal, for aesthetic use · General, Plastic Surgery
- AVEIR VR Real-World Evidence StudyFDA page
ABBOTT MEDICAL · Leadless pacemaker · Cardiovascular
- Cordella Pulmonary Artery Sensor System (CorPASS)FDA page
Endotronix, Inc. · System, hemodynamic, implantable · Cardiovascular
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.