BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S125 · Decision May 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787
    PMA Number
    P860004
    Supplement Number
    S125
    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, 2012
    Date Received
    April 19, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SUBJECT ASCENDA CATHETER, WHICHCONSIST OF TWO MODELS (8780 AND 8781) (HAT ARE IDENTICAL IN COMPONENTS AND ACCESSORIES AND DIFFER ONLY IN THEIR TOTAL LENGTH. THIS CATHETER DIFFERS FROM THE CURRENT INTRATHECAL CATHETERS USED WITH MEDTRONIC IMPLANTABLE PUMPS BY THE FOLLOWING MODIFICATIONS: 1) MULTI-LAYERED CATHETER BODY THAT RESISTS CUTS, FRACTURES, AND OCCLUSIONS; 2) BI-WING ANCHOR WITH NEW ANCHOR DISPENSER DESIGNED TO PREVENT CATHETER DISLODGMENT; 3) CATHETER CONNECTOR THAT PREVENTS PUNCTURE OF THE CATHETER BODY; AND 4) MODIFIED SUTURELESS PUMP CONNECTOR DESIGN TO PREVENT OCCLUSION.

    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