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

    PMA: P010031 · Supplement: S408 · Decision Dec 16, 2013
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D
    PMA Number
    P010031
    Supplement Number
    S408
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 16, 2013
    Date Received
    November 18, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    A NEW LASER WELDING STATION FOR THE BATTERY ELECTRICAL CONNECTION PROCESS AS WELL AS A CHANGE IN MANUFACTURING LOCATION FOR THE LASER WELDING PROCESS AND OPEN CIRCUIT VOLTAGE INSPECTION (OCV).