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 2016-12-22

Separator for therapeutic purposes, membrane automated blood cell/plasma

Applicant Vantive US Healthcare, LLC

PMA Number P830063

Class 3

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PMA 2016-12-22

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant Medtronic, Inc.

PMA Number P960009

Class 3

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PMA 2016-12-21

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore & Associates, Inc.

PMA Number P020004

Class 3

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PMA 2016-12-21

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

Applicant Boston Scientific Corp

PMA Number P010012

Class 3

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PMA 2016-12-21

Implant, cochlear

Applicant Cochlear Americas

PMA Number P970051

Class 3

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PMA 2016-12-21

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Smith & Nephew, Inc.

PMA Number P030022

Class 3

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PMA 2016-12-21

Wearable automated external defibrillator

Applicant Zoll Manufacturing Corporation

PMA Number P010030

Class 3

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PMA 2016-12-21

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Smith & Nephew, Inc.

PMA Number P150030

Class 3

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PMA 2016-12-21

Implant, auditory brainstem

Applicant Cochlear Americas

PMA Number P000015

Class 3

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PMA 2016-12-21

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P980035

Class 3

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PMA 2016-12-21

STENT, CORONARY

Applicant Boston Scientific Corp

PMA Number P130030

Class 3

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PMA 2016-12-21

Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Applicant Smith & Nephew, Inc.

PMA Number P040033

Class 3

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