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 2016-11-07

Somatic gene mutation detection system

Applicant Roche Molecular Systems, Inc.

PMA Number P110020

Class 3

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PMA 2016-11-06

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant ABBOTT MEDICAL

PMA Number P960030

Class 3

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PMA 2016-11-06

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant ABBOTT MEDICAL

PMA Number P960013

Class 3

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PMA 2016-11-02

Device, incontinence, mechanical/hydraulic

Applicant Uromedica, Inc.

PMA Number P130018

Class 3

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PMA 2016-11-01

Prosthesis, metatarsophalangeal joint cartilage replacement implant

Applicant Cartiva, Inc.

PMA Number P150017

Class 3

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PMA 2016-11-01

STENT, ILIAC

Applicant Boston Scientific Scimed, Inc.

PMA Number P940019

Class 3

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PMA 2016-11-01

STENT, ILIAC

Applicant Boston Scientific Corp

PMA Number P110035

Class 3

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PMA 2016-11-01

SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Applicant Boston Scientific Corp

PMA Number P930031

Class 3

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PMA 2016-11-01

Stent, central venous

Applicant Boston Scientific Corporation

PMA Number P980033

Class 3

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PMA 2016-10-28

Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Applicant Insightec, Ltd.

PMA Number P040003

Class 3

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PMA 2016-10-28

Drug-eluting sinus stent

Applicant Intersect Ent.

PMA Number P100044

Class 3

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PMA 2016-10-28

Cochlear implant with combined electrical stimulation and acoustic amplification

Applicant Cochlear Americas

PMA Number P130016

Class 3

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