BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P990034 · Supplement: S018 · Decision Oct 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    ISOMED IMPLANTABLE INFUSION SYSTEMS
    PMA Number
    P990034
    Supplement Number
    S018
    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 6, 2010
    Date Received
    April 20, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO: 1) UPDATE THE LABELING FOR THESE DEVICES TO SPECIFICALLY REFERENCE INFUMORPH (PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION) IN THE TREATMENT OF CHRONIC INTRACTABLE PAIN; AND 2) TO ADD LANGUAGE TO IDENTIFY THE MAXIMUM CONCENTRATION FOR INFUMORPH THAT CAN BE DELIVERED THROUGH THE ISOMED IMPLANTABLE INFUSION SYSTEMS.

    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