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 2016-12-15

intraocular lens

Applicant Alcon Laboratories, Inc.

PMA Number P930014

Class 3

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PMA 2016-12-14

permanent pacemaker Electrode

Applicant Medtronic, Inc.

PMA Number P120017

Class 3

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PMA 2016-12-14

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P140031

Class 3

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PMA 2016-12-14

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

Applicant Roche Diagnostics Corp.

PMA Number P110025

Class 2

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PMA 2016-12-14

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P900061

Class 3

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PMA 2016-12-14

Ventricular (assist) bypass

Applicant ABBOTT MEDICAL

PMA Number P060040

Class 3

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PMA 2016-12-14

CATHETER, CORONARY, ATHERECTOMY

Applicant Boston Scientific Corp

PMA Number P980037

Class 3

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PMA 2016-12-14

Stent, carotid

Applicant Boston Scientific Corp

PMA Number P050019

Class 3

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PMA 2016-12-14

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic, Inc.

PMA Number P980050

Class 3

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PMA 2016-12-14

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant W. L. Gore & Associates, Inc.

PMA Number P160004

Class 3

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PMA 2016-12-14

Implanted brain stimulator for epilepsy

Applicant NeuroPace, Inc.

PMA Number P100026

Class 3

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PMA 2016-12-14

Surgical cardiac ablation device, for treatment of atrial fibrillation

Applicant AtriCure, Inc.

PMA Number P100046

Class 3

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