BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940031 · Supplement: S001 · Decision Feb 20, 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
    S001
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 20, 1996
    Date Received
    June 26, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE PULSE GENERATOR MODELS, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE