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    K Number
    K032034
    Device Name
    ANS AXXESS PERCUTANEOUS LEAD
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2003-10-03

    (94 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANS AXXESS PERCUTANEOUS LEAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANS Axxess™ Percutaneous Leads (41XX Series) are designed to be utilized as the lead component of spinal cord stimulation systems and is used to aid in the management of chronic pain of the trunk and/or extremities.

    The ANS Axxess™ Percutaneous Lead system is designed to be used with the following devices:

    ANS Renew Receiver (34XX series) and Transmitter (35XX series) ANS Lead Extension Models 3341, 3342, 3343, and 3346

    Device Description

    ANS Axxess™ Percutaneous Lead, Models 4143, 4146, 4153 and 4156

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a medical device called "ANS Axxess Percutaneous Lead". It does not contain any information regarding acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot provide the requested information based on the input document.

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