BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S003 · Decision Jul 27, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
    PMA Number
    P980016
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 27, 1999
    Date Received
    February 5, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Model 7229 (GEM(TM) II VR) Implantable Cardioverter Defibrillator and Model 9964 Application Software and the quality assurance test method and specification for screening the GEM(TM) II VR for premature battery depletion, and the revised L222 integrated circuit.