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510(k) Data Aggregation

    K Number
    K030674
    Device Name
    MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2003-03-28

    (24 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AXXESS™ Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities.

    The AXXESS™ lead system is designed to be used with the following devices:

    • Medtronic® Mattrix® Model 3272 RF system receiver and compatible transmitter, or .
    • Medtronic® X-TREL® Model 3470 RF system receiver and compatible transmitter ● using the Medtronic® Model 7495 Quadripolar extension , and
    • Medtronic® Model 3550-05 Percutaneous Extension with the Medtronic® Model 3550-. 03 Screener cable, and
    • The Medtronic® Model 3628 DualScreen™ Screener using Axxess Screener Cable or ●
    • The ANS TS-8 or MNT90T/TR-16 Test Stimulator using Axxess Screener Cable. ●
    Device Description

    Axxess Spinal Cord Stimulation Lead, Model 8000 Series

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a spinal cord stimulation lead. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot fulfill your request based on the provided input.

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