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

    PMA: P860004 · Supplement: S115 · Decision Nov 23, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SYNCHROMED INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S115
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 23, 2009
    Date Received
    October 26, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURING PROCESS AND RAW MATERIAL SPECIFICATION CHANGES FOR THE TUBE COMPONENT OF THE DEVICE.