BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S088 · Decision May 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A
    PMA Number
    P860004
    Supplement Number
    S088
    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 1, 2007
    Date Received
    November 8, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) A NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 2) A MODIFIED MANUFACTURING MONITORING PROCESS TO ASSURE CONFORMANCE TO NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 3) A CHANGE TO THE CATHETER TIP MATERIAL FOR CATHETER MODEL 8731SC AND REVISION KIT MODEL 8598A; AND 4) LABELING REVISIONS.

    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