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 2016-10-04

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

Applicant Tandem Diabetes Care, Inc.

PMA Number P140015

Class 3

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PMA 2016-09-29

Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction

Applicant Medtronic Sofamor Danek USA, Inc.

PMA Number P000058

Class 3

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PMA 2016-09-29

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Applicant Abbott Molecular, Inc.

PMA Number P980024

Class 3

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PMA 2016-09-29

MR-guided focused ultrasound system

Applicant Insightec

PMA Number P150038

Class 3

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PMA 2016-09-29

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Endologix, LLC

PMA Number P120006

Class 3

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PMA 2016-09-29

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P910073

Class 3

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PMA 2016-09-28

Somatic gene mutation detection system

Applicant Roche Molecular Systems, Inc.

PMA Number P150044

Class 3

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PMA 2016-09-28

Prosthesis, ankle, uncemented, non-constrained

Applicant Djo Global

PMA Number P050050

Class 3

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PMA 2016-09-28

HEART-VALVE, MECHANICAL

Applicant On-X Life Technologies, Inc.

PMA Number P000037

Class 3

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PMA 2016-09-28

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

Applicant Exactech, Inc.

PMA Number P050039

Class 3

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PMA 2016-09-27

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Applicant Dako Denmark A/S

PMA Number P100024

Class 3

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PMA 2016-09-27

implantable pacemaker Pulse-generator

Applicant ABBOTT MEDICAL

PMA Number P880086

Class 3

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