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

    PMA: P010012 · Supplement: S404 · Decision Dec 7, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D
    PMA Number
    P010012
    Supplement Number
    S404
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 7, 2015
    Date Received
    November 9, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A NEW MANUFACTURING INSPECTION TO VERIFY THE POLARITY OF THE DISCRETE CAPACITOR ARRAY COMPONENT ON THE PRINTED CIRCUIT BOARD.