BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P990034 · Decision Jul 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC ISOMED INFUSION SYSTEM
    PMA Number
    P990034
    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
    July 21, 2000
    Date Received
    June 28, 1999
    Expedited Review
    N
    Docket Number
    00M-1495

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC(R) ISOMED(R) CONSTANT FLOW INFUSION SYSTEM. THIS DEVICE IS INDICATED FOR USE WHEN PATIENT THERAPY REQUIRES THE CHRONIC INFUSION OF APPROVED DRUGS OR FLUIDS.

    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