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

    PMA: P010031 · Supplement: S410 · Decision Dec 17, 2013
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA C RT-D; VIVA S CRT-D; VIVA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S410
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 17, 2013
    Date Received
    November 19, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURE UPDATE TO THE 0.8 ÌM BICMOS (BIPOLAR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) PROCESS FLOW AT THE IC SUPPLIER.