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

    PMA: P010031 · Supplement: S487 · Decision Feb 23, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA- BRAVA QUAD , CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT,VIVA QUAD, QUAD S AND IX CRT-D'S
    PMA Number
    P010031
    Supplement Number
    S487
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 23, 2015
    Date Received
    January 29, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.