BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S108 · Decision Sep 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II IMPLANTABLE INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S108
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 4, 2009
    Date Received
    July 2, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) UPDATED MANUALS WITH THE GENERAL TERM "PLASTIC" TO DESCRIBE THE NEW HUB/CAP MATERIAL AND ADDED OTHER MINOR CLARIFICATIONS;2) ADDED COMPARTMENT TO FORM AN INNER TRAY TO CONTAIN ACCESSORIES - ELIMINATES BAGGING AND REDUCES MANUFACTURING COST;3) INNER TRAY IS PLACED IN AN OUTER TRAY AND SEALED WITH A POLYETHYLENE LID;4) INNER TRAY, INNER LID AND OUTER TRAY MATERIAL CHANGED TO POLYETHYLENE TEREPHTHALATE (PET)FOR IMPROVED RECYCLING; AND5) MODIFIED BOX TO ACCOMMODATE NEW TRAY DESIGN AND ADDITIONAL (EUROPEAN) LANGUAGES INMANUALS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKK Pump, Infusion, Implanted, Programmable