BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S043 · Decision Oct 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER
    PMA Number
    P860004
    Supplement Number
    S043
    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
    October 29, 1999
    Date Received
    October 18, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to the Model 8703W intraspinal catheter. The resulting catheter incorporates the same materials and basic design as Model 8703W except for a closed distal tip with six side holes instead of a single open tip. The device, as modified, will be marketed under the trade name Medtronic(R) Model 8711 Two Piece Intrathecal Catheter and is indicated for the containment and delivery of parenteral drugs to the intrathecal space of the spinal cord.

    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