BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S018 · Decision May 14, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEM DR/GEM II DR/GEM II VR
    PMA Number
    P980016
    Supplement Number
    S018
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 14, 2001
    Date Received
    April 17, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE GENERAL USE INDICATION FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS MICRO JEWEL 7221, MICRO JEWEL II 7223, GEM DR 7271, GEM II DR 7273 AND GEM II VR 7229 AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS.