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 2026-08-07

Cardiac ablation percutaneous catheter

Applicant St Jude Medical

PMA Number P960016

Class 3

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PMA 2026-08-07

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant St Jude Medical

PMA Number P130026

Class 3

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PMA 2026-08-07

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

Applicant Irvine Biomedical, Inc.

PMA Number P060019

Class 3

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PMA 2026-08-07

Implant, dermal, for aesthetic use

Applicant Tiger Aesthetics Medical, LLC

PMA Number P020012

Class 3

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PMA 2026-08-07

Implanted electrical device intended for treatment of fecal incontinence

Applicant Boston Scientific Corporation

PMA Number P190006

Class 3

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PMA 2026-08-07

Stimulator, electrical, implantable, for incontinence

Applicant Boston Scientific Corporation

PMA Number P180046

Class 3

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PMA 2026-08-07

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

Applicant Organox Limited

PMA Number P200035

Class 3

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PMA 2026-08-07

Agent, absorbable hemostatic, non-collagen based

Applicant Baxter Healthcare Corporation

PMA Number P210036

Class 3

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PMA 2026-08-06

Coronary drug-eluting stent

Applicant Medinol, Ltd.

PMA Number P170008

Class 3

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PMA 2026-08-06

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

Applicant Medtronic, Inc.

PMA Number P240013

Class 3

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PMA 2026-08-05

Automated insulin dosing device system, single hormonal control

Applicant Medtronic Minimed, Inc.

PMA Number P160017

Class 3

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PMA 2026-08-05

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P030036

Class 3

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