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

    PMA: P010031 · Supplement: S264 · Decision Aug 4, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II/CONSULTA/MAXIMO II
    PMA Number
    P010031
    Supplement Number
    S264
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 4, 2011
    Date Received
    July 6, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.