BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S013 · Decision Oct 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
    PMA Number
    P890055
    Supplement Number
    S013
    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
    October 18, 2002
    Date Received
    June 6, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INDICATIONS FOR USE TO INCLUDE GLYCERIN INJECTION AS AN INFUSATE FOR USE WITH PATIENTS WHO ARE RECEIVING CONTINUOUS HEPATIC ARTERIAL FUDR CHEMOTHERAPY WITH THE ARROW INTERNATIONAL MODEL 3000 SERIES OF IMPLANTABLE INFUSION PUMPS TO KEEP THE CATHETER PATENT OR TO EXTEND THE REFILL INTERVAL FOR PATIENTS WHO REQUIRE THERAPY OR WITHDRAWAL.

    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