BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P010031 · Supplement: S504 · Decision Jul 20, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S504
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 20, 2015
    Date Received
    July 1, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    UPDATE TO THE MANUFACTURING PROCESS FOR THE BATTERY ASSEMBLIES BY ADDING NEW EQUIPMENT TO THE BATTERY HEADER WELD FOR THE DEVICES.