Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 2025-11-05

Nucleic Acid Based Assay, Microsatellite Instability

Applicant Promega Corporation

PMA Number P240026

Class 3

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PMA 2025-10-30

Permanent defibrillator electrodes

Applicant Medtronic, Inc.

PMA Number P240036

Class 3

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PMA 2025-10-22

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Life Technologies Corporation

PMA Number P240040

Class 3

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PMA 2025-10-17

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Beckman Coulter, Inc.

PMA Number P230015

Class 2

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PMA 2025-10-04

Prosthesis, mitral valve, percutaneously delivered

Applicant ABBOTT MEDICAL

PMA Number P240042

Class 3

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PMA 2025-09-10

intraocular lens

Applicant Beaver Visitec International, Inc.

PMA Number P240038

Class 3

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PMA 2025-09-09

Barrier, absorbable, adhesion

Applicant Womed Sas

PMA Number P240015

Class 3

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PMA 2025-09-08

Implant, dermal, for aesthetic use

Applicant Croma-Pharma GmbH

PMA Number P240008

Class 3

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PMA 2025-08-27

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

Applicant Kardium, Inc.

PMA Number P240044

Class 3

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PMA 2025-08-15

Nucleic Acid Based Assay, Microsatellite Instability

Applicant Biocartis Us, Inc.

PMA Number P250005

Class 3

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PMA 2025-08-15

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Applicant Agilent Technologies, Inc.

PMA Number P250004

Class 3

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PMA 2025-08-15

Stimulator, electrical, implantable, for incontinence

Applicant Neuspera Medical, Inc.

PMA Number P240031

Class 3

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