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 2026-09-16

Stimulator, autonomic nerve, implanted for stroke rehabilitation

Applicant Mobia Medical, Inc.

PMA Number P210007

Class 3

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PMA 2026-09-16

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant Guardant Health, Inc.

PMA Number P230009

Class 3

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PMA 2026-09-16

Percutaneously Delivered Prostheses and Tricuspid Valves

Applicant Edwards Lifesciences, LLC

PMA Number P230013

Class 3

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PMA 2026-09-16

Filler, bone void, synthetic peptide

Applicant Cerapedics, Inc.

PMA Number P240001

Class 3

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PMA 2026-09-15

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

Applicant Biosense Webster, Inc.

PMA Number P030031

Class 3

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PMA 2026-09-15

Cardiac ablation percutaneous catheter

Applicant Biosense Webster, Inc.

PMA Number P040036

Class 3

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PMA 2026-09-15

Device, thermal ablation, endometrial

Applicant Channel Medsystems, Inc.

PMA Number P180032

Class 3

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PMA 2026-09-15

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

Applicant Biosense Webster, Inc.

PMA Number P210027

Class 3

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PMA 2026-09-15

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

Applicant Biosense Webster, Inc.

PMA Number P240006

Class 3

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PMA 2026-09-15

Nucleic Acid Based Assay, Microsatellite Instability

Applicant Promega Corporation

PMA Number P250046

Class 3

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PMA 2026-09-14

Implanted electrical device intended for treatment of fecal incontinence

Applicant Medtronic Neuromodulation

PMA Number P080025

Class 3

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PMA 2026-09-14

Device, incontinence, mechanical/hydraulic

Applicant Boston Scientific Corp

PMA Number P000053

Class 3

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