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 2016-12-19

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

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P010031

Class 3

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PMA 2016-12-19

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Applicant Roche Molecular Systems, Inc.

PMA Number P150015

Class 2

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PMA 2016-12-19

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P980016

Class 3

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PMA 2016-12-19

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

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P030036

Class 3

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PMA 2016-12-19

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic, Inc.

PMA Number P010015

Class 3

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PMA 2016-12-19

Device, hemostasis, vascular

Applicant Abbott Vascular Devices

PMA Number P050007

Class 3

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PMA 2016-12-19

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

Applicant Medtronic, Inc.

PMA Number P950024

Class 3

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PMA 2016-12-19

Implantable cardioverter defibrillator (non-CRT)

Applicant ABBOTT MEDICAL

PMA Number P910023

Class 3

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PMA 2016-12-19

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

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P830061

Class 3

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PMA 2016-12-19

Hepatitis Viral B DNA Detection

Applicant Roche Molecular Systems, Inc.

PMA Number P150014

Class 2

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PMA 2016-12-19

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Boston Scientific Corporation

PMA Number P140028

Class 3

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PMA 2016-12-19

Coronary drug-eluting stent

Applicant Abbott Vascular, Inc.

PMA Number P070015

Class 3

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