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

    PMA: P010031 · Supplement: S155 · Decision Jun 17, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/MAXIMO II/CONSULTA/CONCERTO II CRT
    PMA Number
    P010031
    Supplement Number
    S155
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 17, 2009
    Date Received
    May 18, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A NEW BACK FILL LASER WELD UNIT.