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

    PMA: P010031 · Supplement: S254 · Decision Jun 8, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO ICD/CONSULTA/CONCERTO II/MAXIMO II CRT-D/INSYNC II/III MARQUIS/MARQUIS DR/INSYNC MARQUIS/MAXIMO/SENTRY
    PMA Number
    P010031
    Supplement Number
    S254
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 8, 2011
    Date Received
    May 9, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.