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 2016-03-24

SYSTEM, ESOPHAGEAL PACING

Applicant Cardiocommand, Inc.

PMA Number P840002

Class 3

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PMA 2016-03-22

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P110021

Class 3

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PMA 2016-03-22

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P100041

Class 3

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PMA 2016-03-15

Computer-assisted personalized sedation system

Applicant Scott Laboratories, Inc.

PMA Number P080009

Class 3

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PMA 2016-02-29

Lenses, soft contact, extended wear

Applicant Unilens Corp., USA

PMA Number P890040

Class 3

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PMA 2016-02-16

Coronary drug-eluting stent

Applicant Boston Scientific Corp

PMA Number P100023

Class 3

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PMA 2016-02-12

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant St. Jude Medical, Inc.

PMA Number P880006

Class 3

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PMA 2016-02-04

Implanted fecal incontinence device

Applicant Boston Scientific Corp

PMA Number P010020

Class 3

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PMA 2016-01-04

Device, thermal ablation, endometrial

Applicant Gynecare, Inc.

PMA Number P970021

Class 3

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