BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S055 · Decision Dec 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM
    PMA Number
    P860004
    Supplement Number
    S055
    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
    December 17, 2002
    Date Received
    November 29, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE 8870 SYNCHROMED APPLICATION SOFTWARE, APPROVED AS P860004/S052, FOR USE WITH THE N'VISION PROGRAMMING SYSTEM CONTAINED ON MODEL 8870 APPLICATION CARD. THE SPECIFIC CHANGES ARE: 1) A CHANGE TO THE 8870 SYNCHROMED APPLICATION PROTOCOL DRIVER TO ENSURE SYNCHRONIZATION AND 2) A MICROPROCESSOR-RESET FEATURE TO THE THERAPY STOP FUNCTION TO RESET THE STACK POINTER.

    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