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

    PMA: P010031 · Supplement: S424 · Decision Feb 27, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S424
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 27, 2014
    Date Received
    January 30, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD AN ADDITIONAL INCOMING INSPECTION TEST OF THE RAW MATERIAL USED TO MANUFACTURE THE CAPACITOR FEED THROUGH DEFORMATION ELEMENTS FOR THE DEVICES.