BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P990034 · Supplement: S001 · Decision Nov 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    ISOMED CONSTANT FLOW INFUSION PUMP
    PMA Number
    P990034
    Supplement Number
    S001
    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
    November 20, 2000
    Date Received
    October 30, 2000
    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 MODEL 8472 PUMP: 1) MODIFICATION OF THE MOUNTING OF THE BELLOWS INFUSATE RESERVOIR; 2) SLIGHT CHANGES IN THE CONFIGURATION OF FIVE COMPONENT PARTS IN ORDER TO MAINTAIN THE HEIGHTS OF THE PUMPS FOLLOWING THE CHANGE IN MOUNTING; AND 3) REQUIRED CHANGES IN FIVE WELDS TO FACILITATE THE PREVIOUSLY STATED MODIFICATIONS.

    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