BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940031 · Supplement: S004 · Decision Oct 18, 1996
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VIGOR(TM) DR PACEMAKER SYSTEM
    PMA Number
    P940031
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 18, 1996
    Date Received
    January 25, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    NEW PULSE GENERATOR MODE THE VIGOR(R) DR FAMILY OF PACEMAKER SYSTEMS