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
- LungFX DeviceFDA page
Lung Bioengineering, Inc. · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Gastroenterology, Urology
- BIOexpressFDA page
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
- ZOLL R Series Monitor/DefibrillatorFDA page
ZOLL Medical Corporation · Automated external defibrillators (non-wearable) · Cardiovascular
- BIOexpressFDA page
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
- VISTAKON® (senofilcon A) Brand Contact LensesFDA page
Vistakon, Division of Johnson & Johnson Vision Car · Lenses, soft contact, extended wear · Ophthalmic
- Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemsFDA page
Medtronic Vascular · Coronary drug-eluting stent · Cardiovascular
- Altius® Direct Electrical Nerve Stimulation SystemFDA page
Neuros Medical, Inc. · stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb · Neurology
- LungFX DeviceFDA page
Lung Bioengineering, Inc. · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Gastroenterology, Urology
- MEDTRONIC SELECTSECURE LEAD MODEL 3830FDA page
Medtronic Cardiac Rhythm Disease Management · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · Cardiovascular
- AED 3 Defibrillator with Uni-PadzFDA page
ZOLL Medical Corporation · Automated external defibrillators (non-wearable) · Cardiovascular
- Saluda Medical Evoke SCS SystemFDA page
Saluda Medical Pty, Ltd. · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
- PerQseal® Elite Vascular Closure DeviceFDA page
Vivasure Medical , Ltd. · Device, hemostasis, vascular · Cardiovascular
- Cordelia Pulmonary Artery Pressure Sensor System (CorPASS)FDA page
Endotronix, Inc. · System, hemodynamic, implantable · Cardiovascular
- Volt PFA SystemFDA page
ABBOTT MEDICAL · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation · Cardiovascular
- S.M.A.R.T. ® CONTROL® Nitinol Stent SystemFDA page
Cordis US Corporation · STENT, ILIAC · Cardiovascular
- S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ Vascular Stent SystemFDA page
Cordis US Corporation · STENT, SUPERFICIAL FEMORAL ARTERY · Cardiovascular
- Saluda Medical Evoke SCS SystemFDA page
Saluda Medical Pty, Ltd. · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
- Esteem®FDA page
Envoy Medical Corporation · Implant, hearing, active, middle ear, totally implanted · Ear, Nose, Throat
- Artegraft Collagen Vascular GraftFDA page
LeMaitre Vascular, Inc. · Tissue graft of 6mm and greater · Cardiovascular
- Vercise DBS SystemsFDA page
Boston Scientific Corp · Stimulator, electrical, implanted, for parkinsonian symptoms · Neurology
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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.