BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S257 · Decision Sep 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    ASCENDA INTRATHECAL CATHETERS AND KITS
    PMA Number
    P860004
    Supplement Number
    S257
    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
    September 27, 2016
    Date Received
    June 30, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes for Medtronics Ascenda Intrathecal Catheter and Revision Kit including: Implant Manuals Catheter Length Measurement; Implant Manuals Materials Table; Implant Manuals Verb change; Implant Manuals Reference to Model 8784 Kit added; Implant Manuals Other clarification, administrative and style changes; Package Labels Catheter Length Measurements; Package Labels Addition of symbols; Package Labels Other minor changes. These changes impact the manuals associated with the following models: Full Catheter Kit 8780 Ascenda Intrathecal Catheter (86cm spinal segment); Full Catheter Kit 8781 Ascenda Intrathecal Catheter (66cm spinal segment); Revision Catheter Kit 8782 Ascenda Intrathecal Catheter (86cm spinal segment revision kit); Revision Catheter Kit 8784 Ascenda Intrathecal Catheter (74cm spinal segment revision kit); Revision Catheter Kit 8785 Ascenda Accessory Kit. These changes impact the packaging labels associated with the following labels: Model 8780 Implant Manual; Model 8781 Implant Manual; Model 8782 Implant Manual; Model 8784 Implant Manual; Model 8780 Package Label; Model 8781 Package Label; Model 8782 Package Label; Model 8784 Package Label; Model 8785 Package Label.

    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