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510(k) Data Aggregation

    K Number
    K032751
    Device Name
    MODIFICATION TO RENEW LEAD EXTENSION
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2003-10-06

    (31 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

    ANS Renew Lead Extensions are indicated for 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 multidisciplinary approach. Lead Extensions are intended to be used with Advanced Neuromodulation Systems', leads, receivers, transmitters, and antennae.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to a medical device company regarding a 510(k) premarket notification. It states that the device is substantially equivalent to legally marketed predicate devices.

    This document does not contain any information about:

    • Acceptance criteria for device performance.
    • A study that proves the device meets specific acceptance criteria.
    • Sample sizes for test sets or training sets.
    • Data provenance, expert qualifications, adjudication methods, or ground truth establishment.
    • MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request based on the text provided.

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