BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S248 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Epilepsy
    Trade Name
    VNS Therapy System
    PMA Number
    P970003
    Supplement Number
    S248
    Device Class
    FDA Class 3
    Product Code
    LYJ
    Generic Name
    Stimulator, autonomic nerve, implanted for epilepsy
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2025
    Date Received
    August 6, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for:1. VNS Therapy Epilepsy Physician’s Manuals:Update to create a new “Management of Depression as a Comorbidity” section to inform physicians that depression is a common comorbidity for epilepsy patients and to follow standard medical practice for follow up with these patients and monitoring of their depressive symptoms.• Document 26-0011-0100 (Epilepsy Manual; Appendix 1, page 117) New Section added to the Post-Implant Management Chapter: Follow-up Visits: Long-Term Follow Up Section- 7.1.2.2.1 Management of Depression as a Comorbidity:Depression is a common comorbidity in patients with epilepsy. In accordance with standard medical practice, patients with a current or prior diagnosis of depression should be advised to report any new or worsening depressive symptoms, including suicidal ideation.2. VNS Therapy Epilepsy Patient Guide:Update to create a new “Patients with Depression” section to inform patients that may also have depression to follow up with their doctor if they have new or worsening depressive symptoms.• Document 26-0011-1600 (Epilepsy Patient Guide; Appendix 2, page 19). New section added to the Follow Up After Surgery Chapter: After Treatment Begins Section- 6.4.3 Patients with Depression:Some people with epilepsy also have depression. If you have depression now or had it in the past, it is important to monitor your mood and mental health. Contact your doctor if you notice any new or worsening depressive symptoms, including suicidal thoughts.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy