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

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore & Associates, Inc.

PMA Number P040043

Class 3

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PMA 2016-12-16

Implant, dermal, for aesthetic use

Applicant Allergan

PMA Number P110033

Class 3

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PMA 2016-12-16

Pump, infusion, implanted, programmable

Applicant Infusyn Therapeutics, LLC

PMA Number P080012

Class 3

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PMA 2016-12-16

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Lutonix

PMA Number P130024

Class 3

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PMA 2016-12-16

Pump, infusion, insulin, to be used with invasive glucose sensor

Applicant Animas Corp.

PMA Number P130007

Class 3

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PMA 2016-12-16

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Applicant W. L. Gore & Associates, Inc.

PMA Number P130006

Class 3

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PMA 2016-12-16

implantable pacemaker Pulse-generator

Applicant MicroPort CRM USA, Inc.

PMA Number P950029

Class 3

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PMA 2016-12-16

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant W. L. Gore & Associates, Inc.

PMA Number P040037

Class 3

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PMA 2016-12-16

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant Guidant Corp.

PMA Number P030005

Class 3

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PMA 2016-12-16

Coronary drug-eluting stent

Applicant Boston Scientific Corporation

PMA Number P150003

Class 3

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PMA 2016-12-16

OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Applicant Pfm Medical, Inc.

PMA Number P120009

Class 3

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PMA 2016-12-16

Implant, dermal, for aesthetic use

Applicant Allergan

PMA Number P050047

Class 3

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