BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S251 · Decision Nov 25, 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 Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand
    PMA Number
    P970003
    Supplement Number
    S251
    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
    November 25, 2025
    Date Received
    September 2, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a new version of the M3100 v2.0 Clinician Programmer update, including a new Pause Therapy function, new version of the M2000 v1.1.3.0 Wand, and updates to the Digital Product Platform

    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