BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S005 · Decision Apr 15, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEM II DR MODEL 7273
    PMA Number
    P980016
    Supplement Number
    S005
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 15, 1999
    Date Received
    March 31, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for screening the Medtronic(R) Model 7271 GEM(TM) II Dual Chamber Implantable Cardioverter Defibrillators for premature battery depletion.