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

    PMA: P010012 · Supplement: S381 · Decision Jan 9, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
    PMA Number
    P010012
    Supplement Number
    S381
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 9, 2015
    Date Received
    December 15, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITIONAL SUPPLIER FOR THE POWER INDUCTORS USED IN THE DEVICES.