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510(k) Data Aggregation

    K Number
    K110609
    Device Name
    EPIDUCER LEAD DELIVERY SYSTEM
    Manufacturer
    ST. JUDE MEDICAL
    Date Cleared
    2011-06-24

    (113 days)

    Product Code
    LHG, GZB
    Regulation Number
    882.5880
    Why did this record match?
    Product Code :

    LHG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epiducer system is an accessory to the leads component of St. Jude Medical Neuromodulation Division neurostimulation systems, which are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in a multi-disciplinary approach. The Epiducer™ lead delivery system is intended to introduce Lamitrode S-Series paddle leads and/or St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below the L1 vertebra.
    Device Description
    Not Found
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