BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S012 · Decision Dec 13, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229
    PMA Number
    P980016
    Supplement Number
    S012
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 13, 1999
    Date Received
    November 8, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the circuitry of the Medtronic(R) Models 7273 and 7229 Implantable Cardioverter Defibrillators.