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

    PMA: P010012 · Supplement: S386 · Decision Apr 2, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INOGEN, ORIGEN AND DYNAGEN CRT-D'S
    PMA Number
    P010012
    Supplement Number
    S386
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 2, 2015
    Date Received
    March 25, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ACCEPTANCE OF NEW TEMPERATURE RECORDERS FOR USE AT THE CLONMEL, IRELAND LOCATION.