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 2025-03-20

Pulse-generator, single chamber, sensor driven, implantable

Applicant Medtronic, Inc.

PMA Number P850051

Class 3

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PMA 2025-03-19

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant New Day Diagnostics, LLC

PMA Number P130001

Class 3

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PMA 2025-03-17

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number P980006

Class 3

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PMA 2025-03-05

Excimer laser system

Applicant Alcon Laboratories, Inc.

PMA Number P020050

Class 3

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PMA 2025-03-03

Caries detection product with drug or biologic

Applicant Calcivis Limited

PMA Number P170029

Class 3

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PMA 2025-02-26

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

Applicant Biosense Webster, Inc.

PMA Number P010068

Class 3

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PMA 2025-02-26

Cardiac ablation percutaneous catheter

Applicant Biosense Webster, Inc.

PMA Number P950005

Class 3

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PMA 2025-02-25

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Applicant Biosense Webster, Inc.

PMA Number P990025

Class 2

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PMA 2025-02-24

Intraocular pressure lowering implant

Applicant Glaukos Corporation

PMA Number P170043

Class 3

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PMA 2025-02-11

Prosthesis, breast, inflatable, internal, saline

Applicant Bimini Health Tech

PMA Number P120011

Class 3

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PMA 2025-02-11

System, laser, photodynamic therapy

Applicant Bausch + Lomb Ireland Limited

PMA Number P050026

Class 3

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PMA 2025-02-06

Excimer laser system

Applicant Technolas Perfect Vision GmbH

PMA Number P990027

Class 3

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