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

    PMA: P010031 · Supplement: S490 · Decision Mar 4, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT)
    PMA Number
    P010031
    Supplement Number
    S490
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 4, 2015
    Date Received
    February 4, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.