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 2025-07-30

Vagus nerve stimulator for rheumatoid arthritis

Applicant SetPoint Medical

PMA Number P240039

Class 3

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PMA 2025-07-24

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors

Applicant Quest Diagnostics Nichols Institute

PMA Number P250002

Class 3

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PMA 2025-07-18

Covered stent vascular connector, hemodialysis access circuit

Applicant Phraxis, Inc.

PMA Number P240004

Class 3

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PMA 2025-07-11

Immunohistochemistry Assay, Antibody, MET

Applicant Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

PMA Number P240037

Class 3

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PMA 2025-06-23

Stent, carotid

Applicant InspireMD, Ltd.

PMA Number P240029

Class 3

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PMA 2025-05-01

System, laser, photodynamic therapy

Applicant Sun Pharmaceutical Industries, Inc.

PMA Number P990019

Class 3

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PMA 2025-04-18

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

Applicant Bio-Rad Laboratories

PMA Number P050048

Class 2

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PMA 2025-03-20

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P930022

Class 3

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PMA 2025-03-20

Pulse-generator, single chamber, sensor driven, implantable

Applicant Medtronic, Inc.

PMA Number P850051

Class 3

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PMA 2025-01-17

Stimulator, bone growth, non-invasive

Applicant Enovis

PMA Number P210016

Class 3

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PMA 2024-12-31

Tricuspid valve repair device, percutaneously delivered

Applicant ABBOTT MEDICAL

PMA Number P230007

Class 3

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PMA 2024-12-23

Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions

Applicant W. L. Gore & Associates, Inc.

PMA Number P230023

Class 3

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