BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S010 · Decision Dec 23, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MODEL 7271 GEM DR ICD
    PMA Number
    P980016
    Supplement Number
    S010
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 1999
    Date Received
    October 21, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for low power hybrid circuitry changes which will improve the patient alert drive transistors, the charge pump circuit and the manufacturing process.