BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S002 · Decision Jan 28, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC MODEL 7273 GEM II DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 9964 (GEM II DR) AP
    PMA Number
    P980016
    Supplement Number
    S002
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 28, 1999
    Date Received
    December 7, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic(R) GEM(TM) II DR Model 7273 Implantable Cardioverter Defibrillator with Medtronic(R) Model 9964 GEM(TM) II DR Programmer Application Software.