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 2016-12-13

replacement Heart-valve

Applicant Edwards Lifesciences, LLC

PMA Number P860057

Class 3

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PMA 2016-12-13

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P130009

Class 3

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PMA 2016-12-13

Pump, infusion, implanted, programmable

Applicant Medtronic, Inc.

PMA Number P990034

Class 3

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PMA 2016-12-13

Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Applicant Depuy, Inc.

PMA Number P830055

Class 3

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PMA 2016-12-13

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant Exact Sciences Corporation

PMA Number P130017

Class 3

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PMA 2016-12-12

AID, SURGICAL, VISCOELASTIC

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P110007

Class 3

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PMA 2016-12-12

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Applicant Boston Scientific Corp

PMA Number P950020

Class 3

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PMA 2016-12-12

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P910077

Class 3

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PMA 2016-12-12

Agent, absorbable hemostatic, non-collagen based

Applicant Davol, Inc.

PMA Number P050038

Class 3

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PMA 2016-12-12

Implant, hearing, active, middle ear, totally implanted

Applicant Envoy Medical Corporation

PMA Number P090018

Class 3

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PMA 2016-12-12

Implantable pulse generator, pacemaker (non-CRT)

Applicant Boston Scientific

PMA Number P150012

Class 3

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PMA 2016-12-12

Implantable pulse generator, pacemaker (non-CRT)

Applicant Boston Scientific Corp

PMA Number N970003

Class 3

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