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

    PMA: P010031 · Supplement: S286 · Decision Jan 18, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA/PROTECTA XT/PROTECTA/PROTECTA DF4
    PMA Number
    P010031
    Supplement Number
    S286
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 18, 2012
    Date Received
    December 20, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING.