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

    PMA: P010031 · Supplement: S255 · Decision Jun 9, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4
    PMA Number
    P010031
    Supplement Number
    S255
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 9, 2011
    Date Received
    May 10, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.