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510(k) Data Aggregation

    K Number
    K090907
    Device Name
    PENTA LEAD KITS, MODELS: 3227-3234
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2009-06-02

    (62 days)

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

    PENTA LEAD KITS, MODELS: 3227-3234

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

    Advanced Neuromodulation Systems Penta Lead Kits are indicated for the management 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 and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Penta lead kits". This document is a regulatory communication and does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies related to the device's performance. Therefore, I cannot extract the requested information from this text.

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