BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S059 · Decision Mar 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED AND SYNCHROMED II IMPLANTABLE INFUSION PUMPS
    PMA Number
    P860004
    Supplement Number
    S059
    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
    March 17, 2004
    Date Received
    February 23, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: THE ADDITION OF TIME LABELS AND A DAILY DOSE FILED TO THE PROGRAMMING SCREENS; THE ADDITION OF RECENTLY APPROVED CATHETER MODELS, MODEL 8731 AND MODEL 8749, TO THE DROP-DOWN LIST; CHANGES TO THE SCREEN USED TO ENTER THE DEMO MODE, AND THE RESULTING UPDATES TO THE PROGRAMMING GUIDES.

    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