BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S015 · Decision Dec 12, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEM III VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD)
    PMA Number
    P980016
    Supplement Number
    S015
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 12, 2000
    Date Received
    November 1, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MEDTRONIC GEM III VR MODEL 7231 ICD AND MEDTRONIC MODEL 9971 (GEM III VR) 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.