BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940031 · Supplement: S009 · Decision Feb 18, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VIGOR(R) DR/SR PACEMAKER SYSTEM
    PMA Number
    P940031
    Supplement Number
    S009
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 18, 1997
    Date Received
    December 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FORT HE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MDOEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.