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

    PMA: P010031 · Supplement: S192 · Decision Apr 28, 2010
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/INSYNC II/MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY
    PMA Number
    P010031
    Supplement Number
    S192
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 28, 2010
    Date Received
    March 29, 2010
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM.