BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010031 · Supplement: S115 · Decision Apr 21, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS
    PMA Number
    P010031
    Supplement Number
    S115
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 21, 2009
    Date Received
    August 4, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE ADDITION OF AN ETHYLENE OXIDE STERILIZER.