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

    PMA: P010012 · Supplement: S402 · Decision Oct 21, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR
    PMA Number
    P010012
    Supplement Number
    S402
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 21, 2015
    Date Received
    September 30, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ELIMINATE AN EQUIPMENT CHECK PERFORMED ON EQUIPMENT USED TO TEST PARYLENE COATING THICKNESS OF BATTERIES AND CAPACITORS USED IN THE DEVICE MODELS.