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

    PMA: P860004 · Supplement: S110 · Decision Aug 20, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SYNCHROMED II INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S110
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 20, 2009
    Date Received
    July 21, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    AUTOMATION OF THE STEP WHERE DATA IS TRANSFERRED FROM THE CALIBRATION TESTING EQUIPMENT TO FACTORYWORKS, THE MANUFACTURING SOFTWARE THAT CONTROLS THE MANUFACTURING OF THE DEVICE.