BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S045 · Decision Apr 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC ONE PIECE VASCULAR CATHETERS
    PMA Number
    P860004
    Supplement Number
    S045
    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
    April 14, 2000
    Date Received
    March 29, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes in the Anchor Rings - The anchor rings at the tip of the Model 8700A catheter are to be changed from a tapered design to a smaller, rounded bead design at the distal end of the catheter; changes to the Catheter Tubing Composition - the composition of the tubing for the Model 8700A, Model 8700V, and Model 8702 catheters is to be changed to Biomedical Grade ETR Q7-4765; changes to the Technical Manual - the Model 8700A, Model 8700V, and Model 8702 catheters are covered in the same technical manual.

    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