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

    PMA: P010031 · Supplement: S138 · Decision Jan 9, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC/INSYNC MARQUIS& MARQUIS II/III/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO/MAXIMO II CRT-D/CONCERTO CRT-D/CONSULTA
    PMA Number
    P010031
    Supplement Number
    S138
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 9, 2009
    Date Received
    December 11, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE STERILIZATION PROCESS.