BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940031 · Supplement: S006 · Decision Nov 12, 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
    S006
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 12, 1996
    Date Received
    October 16, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION FACILITY