BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S010 · Decision May 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE
    PMA Number
    P890055
    Supplement Number
    S010
    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
    May 27, 1999
    Date Received
    May 11, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following modifications to the device: 1)Replacement of the standard 50 ml syring with a calibrated syringe in the refill kit and related labeling; 2) the incorporation of a special bolus winged infusion set; 3) Increase the volume of water placed into the pump reservoir prior to sterilization; 4) Revise the labeling to refer the user to the instruction for use of the device.

    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