BEUDAMED
    Product Code: LYJ FDA class 3

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    Unknown

    The Autonomic Nerve Implanted Stimulator for Epilepsy (product code LYJ) is a surgically implanted neurostimulation device that delivers electrical impulses to autonomic nerve structures, such as the vagus nerve, to reduce the frequency and severity of seizures in patients with refractory epilepsy. It is classified as a Class 3 device requiring Premarket Approval (PMA) and is flagged as an implant given its surgical placement. The device has no formal regulation number or medical specialty designation and is reviewed under the Neurology (NE) panel. It is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LYJ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.