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

    PMA: P010031 · Supplement: S356 · Decision Mar 5, 2013
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA/VIVA S/VIVA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S356
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 5, 2013
    Date Received
    February 7, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    (1) FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; (2) MODIFICATION OF CONTROLLED ENVIRONMENT AREA; (3) NEW PRESSURE TESTER AT SMO FACILITY; AND (4) TEMPORARY GOWNING AREA AND TEMPORARY WALLS AND RELOCATION OF THE MILLING ROOM.