BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P800036 · Supplement: S015 · Decision Sep 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
    PMA Number
    P800036
    Supplement Number
    S015
    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
    September 20, 1995
    Date Received
    September 16, 1987
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGE IN LABELING TO INCLUDE EPIDURAL AND INTRATHECAL ADMINISTRATION OF INFUMORPH 200 & 500 CII (PRESERVATIVE-FREE MORPHINE) IN PATIENTS SUFFERING FROM SEVERE AND PROLONGED PAIN WHO ARE NO LONGER RESPONSIVE TO CONVENTIONAL FORMS OF ANALGESIA

    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