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 2016-12-16

STENT, ILIAC

Applicant Cook Ireland, Ltd.

PMA Number P050017

Class 3

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PMA 2016-12-15

Ventricular (assist) bypass

Applicant Medtronic

PMA Number P100047

Class 3

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PMA 2016-12-15

intraocular lens

Applicant Alcon Laboratories

PMA Number P840060

Class 3

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PMA 2016-12-15

intraocular lens

Applicant Alcon Laboratories

PMA Number P880087

Class 3

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PMA 2016-12-15

HEART-VALVE, MECHANICAL

Applicant ABBOTT MEDICAL

PMA Number P810002

Class 3

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PMA 2016-12-15

Prosthesis, intervertebral disc

Applicant Medtronic Sofamor Danek USA, Inc.

PMA Number P090029

Class 3

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PMA 2016-12-15

Transcatheter septal occluder

Applicant W. L. Gore & Associates, Inc.

PMA Number P050006

Class 3

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PMA 2016-12-15

intraocular lens

Applicant Alcon Laboratories

PMA Number P810032

Class 3

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PMA 2016-12-15

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Medtimo, Inc.

PMA Number P160001

Class 3

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PMA 2016-12-15

Lenses, soft contact, extended wear

Applicant Vistakon, Division of Johnson & Johnson Vision Car

PMA Number P040045

Class 3

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PMA 2016-12-15

Aspiration therapy system

Applicant Aspire Bariatrics, Inc.

PMA Number P150024

Class 3

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PMA 2016-12-15

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant OraSure Technologies, Inc.

PMA Number P080027

Class 2

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