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510(k) Data Aggregation

    K Number
    K022222
    Device Name
    LAMITRODE S-SERIES (S4 AND S8) LEADS
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEM,INC
    Date Cleared
    2002-08-08

    (30 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 Lamitrode S-Series (S4 and S8) Leads, models 3243, 3246, 3283 and 3286, 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. Lamitrode S4 and S8 leads are design to be connected to ANS neurostimulation receiver, Models 3408 and 3416, transmitter models 3508 and 3516 and extension models 3341, 3342, 3343, 3346, 3382, 3383 and 3386.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Lamitrode S-Series Leads. This document does not contain any information regarding acceptance criteria for device performance, details of a study that proves the device meets those criteria, or any of the specific study parameters you asked about (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

    This document is part of a regulatory filing affirming substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot extract the requested information from this text.

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