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

    PMA: P860004 · Supplement: S103 · Decision Jan 14, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SYNCHROMED PUMP AND INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S103
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 14, 2009
    Date Received
    December 15, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.