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
- ROTAPRO Rotational Atherectomy SystemFDA page
Boston Scientific Corp · CATHETER, CORONARY, ATHERECTOMY · Cardiovascular
- PASCAL Precision Transcatheter Valve Repair SystemFDA page
Edwards Lifesciences, LLC · Tricuspid valve repair device, percutaneously delivered · Cardiovascular
- TECNIS Foldable Acrylic IOL with OptiEdge, Model ZA9003FDA page
Johnson & Johnson Surgical Vision, Inc. · intraocular lens · Ophthalmic
- HeartMate 3 Left Ventricular Assist SystemFDA page
ABBOTT MEDICAL · Ventricular (assist) bypass · Cardiovascular
- TECNIS Multi-focal 3-pc, Model ZMA00FDA page
Johnson & Johnson Surgical Vision, Inc. · Lens, multifocal intraocular · Ophthalmic
- Edwards EVOQUE Tricuspid Valve Replacement SystemFDA page
Edwards Lifesciences, LLC · Percutaneously Delivered Prostheses and Tricuspid Valves · Cardiovascular
- ReActiv8 Implantable Neurostimulation SystemFDA page
Mainstay Medical Limited · Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief · Neurology
- SENSAR 3-Piece Monofocal IOL, SENSAR 1-piece IOL, TECNIS Multi-focal 1-pc, TECNIS 1-PC OptiBlue IOL, TECNIS OptiBlue 1-PFDA page
Johnson & Johnson Surgical Vision, Inc. · intraocular lens · Ophthalmic
- BIOexpressFDA page
Biotronik, Inc. · implantable pacemaker Pulse-generator · Cardiovascular
- SQUID Liquid Embolic Agent (LEA)FDA page
Balt USA, LLC · Neurovascular Liquid Embolic Agent · Neurology
- EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery SysteFDA page
Medtronic Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY · Cardiovascular
- Abre Venous Self-Expanding Stent SystemFDA page
Medtronic Vascular, Inc. · Stent, iliac vein · Cardiovascular
- Visi-Pro balloon-Expandable peripheral stent systemFDA page
Medtronic Vascular, Inc. · STENT, ILIAC · Cardiovascular
- NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemFDA page
Zimmer, Inc. · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing · Orthopedic
- MI Cancer SeekFDA page
Caris Life Sciences · Next generation sequencing oncology panel, somatic or germline variant detection system · Medical Genetics
- Protégé GPS Self-Expanding Peripheral Stent System; Protégé RX Self-Expanding Carotid Stent SystemFDA page
Medtronic Vascular, Inc. · Stent, carotid · Cardiovascular
- DETOUR SystemFDA page
Endologix, LLC · Stent graft, bypass, superficial femoral artery · Cardiovascular
- Charger SetPoint SystemFDA page
SetPoint Medical · Vagus nerve stimulator for rheumatoid arthritis · Neurology
- BIOexpressFDA page
Biotronik, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) · Cardiovascular
- SynchroMed Infusion System, Ascenda Intrathecal CathetersFDA page
Medtronic, Inc. · Pump, infusion, implanted, programmable · General Hospital
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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.