Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA Approvals

Premarket Approval devices tracked by MedTracker

PMA 2026-08-17

intraocular lens

Applicant Alcon Laboratories, LLC

PMA Number P190018

Class 3

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PMA 2026-08-14

Coronary drug-eluting stent

Applicant Medtronic Vascular

PMA Number P160043

Class 3

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PMA 2026-08-13

Device, impotence, mechanical/hydraulic

Applicant Coloplast Corp.

PMA Number P000006

Class 3

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PMA 2026-08-13

Ablation catheter, renal denervation

Applicant Recor Medical, Inc.

PMA Number P220023

Class 3

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PMA 2026-08-12

Implantable cardioverter defibrillator (non-CRT)

Applicant ABBOTT MEDICAL

PMA Number P910023

Class 3

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PMA 2026-08-12

Ventricular (assist) bypass

Applicant ABBOTT MEDICAL

PMA Number P060040

Class 3

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PMA 2026-08-12

Stimulator, autonomic nerve, implanted for epilepsy

Applicant LivaNova USA, Inc.

PMA Number P970003

Class 3

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PMA 2026-08-12

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant ABBOTT MEDICAL

PMA Number P030054

Class 3

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PMA 2026-08-11

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant ABBOTT MEDICAL

PMA Number P250022

Class 3

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PMA 2026-08-10

Aortic valve, prosthesis, percutaneously delivered

Applicant Medtronic, Inc.

PMA Number P130021

Class 3

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PMA 2026-08-10

OCT imaging system with AI/ML software for adjunctive detection of breast cancer

Applicant Perimeter Medical Imaging Ai, Inc.

PMA Number P250008

Class 3

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PMA 2026-08-07

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant ABBOTT MEDICAL

PMA Number P110016

Class 3

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