BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S014 · Decision Nov 29, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE
    PMA Number
    P980016
    Supplement Number
    S014
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 29, 2000
    Date Received
    September 11, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MEDTRONIC GEM III DR MODEL 7275 ICD AND MEDTRONIC MODEL 9970 (GEM III DR) PROGRAMMER APPLICATION SOFTWARE. THE DEVICE, AS MODIFIED, IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIA.