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
- Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) ChargerFDA page
ABBOTT MEDICAL · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
- Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium HyaFDA page
Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC · Ophthalmic
- Clareon Vivity Pro Extended Vision IOLsFDA page
Alcon Laboratories, LLC · Extended depth of focus intraocular lens · Ophthalmic
- Activa Deep Brain Stimulation Therapy System, Percept PC BrainSenseFDA page
Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor · Neurology
- CentriMag Circulatory Support SystemFDA page
Abbott · Ventricular (assist) bypass · Cardiovascular
- SynchroMed Infusion System, Ascenda Intrathecal CathetersFDA page
Medtronic, Inc. · Pump, infusion, implanted, programmable · General Hospital
- Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)FDA page
ABBOTT MEDICAL · Stimulator, electrical, implanted, for parkinsonian tremor · Neurology
- TorEx Lung Perfusion System; TorEx Lung PerfusateFDA page
Traferox Technologies, Inc. · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Gastroenterology, Urology
- Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)FDA page
ABBOTT MEDICAL · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
- Abre Venous Self-expanding Stent SystemFDA page
Medtronic Vascular, Inc. · Stent, iliac vein · Cardiovascular
- Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Specify,FDA page
Medtronic Neuromodulation · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
- CELT ACD VASCULAR CLOSURE DEVICEFDA page
Vasorum, Ltd. · Device, hemostasis, vascular · Cardiovascular
- Vercise Deep Brain Stimulation (DBS) SystemsFDA page
Boston Scientific Corp · Stimulator, electrical, implanted, for parkinsonian symptoms · Neurology
- Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) ChargerFDA page
ABBOTT MEDICAL · Stimulator, electrical, implanted, for parkinsonian tremor · Neurology
- EXCOR Pediatric Ventricular Assist DeviceFDA page
Berlin Heart, Inc. · Ventricular (assist) bypass · Cardiovascular
- TorEx Lung Perfusion System; TorEx Lung PerfusateFDA page
Traferox Technologies, Inc. · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Gastroenterology, Urology
- Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPGFDA page
Medtronic, Inc. · Pulse generator, permanent, implantable · Cardiovascular
- Navitor Transcatheter Aortic Valve Implantation SystemFDA page
ABBOTT MEDICAL · Aortic valve, prosthesis, percutaneously delivered · Cardiovascular
- SetPoint SystemFDA page
SetPoint Medical · Vagus nerve stimulator for rheumatoid arthritis · Neurology
- Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-DFDA page
Medtronic Cardiac Rhythm Disease Management · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) · 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.