BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S006 · Decision Jun 16, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC MODEL 7273 GEM II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
    PMA Number
    P980016
    Supplement Number
    S006
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 16, 1999
    Date Received
    May 26, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM(TM) and the Model 7273 GEM(TM) II DR implantable cardioverter defibrillators to correct the premature low battery problem.