BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S050 · Decision May 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    VASCULAR CATHETER
    PMA Number
    P860004
    Supplement Number
    S050
    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
    May 2, 2002
    Date Received
    April 23, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CATHETER MODEL 8708 IN WHICH THE STRAIGHT CONNECTOR IS REPLACED WITH RIGHT ANGLE CONNECTOR, THE NUMBER OF ANCHOR BEADS IS INCREASED TO 12. ALSO, REMOVAL OF ACCESSORY COMPONENTS SPECIFIED AS GUIDE WIRE, TUNNELING ACCESSORIES AND TWO PRE-ATTACHED ANCHORS FROM MODEL 8700A, 8700V AND 8702 PACKAGE. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME MEDTRONIC VASCULAR CATHETER MODEL 8708 AND IS INDICATED FOR USE WITH THE MEDTRONIC IMPLANTABLE INFUSION PUMPS TO PROVIDE FLUID PATHWAY.

    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