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 2025-11-02

Intracranial aneurysm flow diverter

Applicant MicroVention, Inc.

PMA Number P180027

Class 3

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PMA 2025-10-28

Automated external defibrillators (non-wearable)

Applicant Aed Battery Exchange, LLC

PMA Number P190013

Class 3

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PMA 2025-10-27

SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Applicant W. L. Gore & Associates, Inc.

PMA Number P040027

Class 3

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PMA 2025-10-24

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number N16895

Class 3

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PMA 2025-10-22

Stent, carotid

Applicant Abbott Vascular

PMA Number P040012

Class 3

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PMA 2025-10-22

STENT, ILIAC

Applicant Abbott Vascular, Inc.

PMA Number P110028

Class 3

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PMA 2025-10-22

STENT, RENAL

Applicant Abbott Vascular

PMA Number P110001

Class 3

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PMA 2025-10-22

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P190001

Class 3

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PMA 2025-10-17

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

Applicant Siemens Healthcare Diagnostics

PMA Number P030040

Class 2

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PMA 2025-10-17

Cardiac ablation percutaneous catheter

Applicant Boston Scientific Corp

PMA Number P920047

Class 3

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PMA 2025-10-17

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

Applicant Boston Scientific

PMA Number P020025

Class 3

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PMA 2025-10-17

Hepatitis Viral B DNA Detection

Applicant Roche Molecular Systems, Inc.

PMA Number P150014

Class 2

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