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

    PMA: P010031 · Supplement: S251 · Decision May 19, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT
    PMA Number
    P010031
    Supplement Number
    S251
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 19, 2011
    Date Received
    April 26, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.