BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S096 · Decision Feb 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Epilepsy
    Trade Name
    VNS THERAPY SYSTEM
    PMA Number
    P970003
    Supplement Number
    S096
    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
    February 22, 2008
    Date Received
    January 23, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE DEMIPULSE AND PULSE DUO GENERATOR, MODELS 103 AND 104 WHICH PROVIDE INSTRUCTIONAL STEPS IN THE EVENT THAT THE USER ENCOUNTERS A MESSAGE THAT THE PULSE GENERATOR IS CURRENTLY DISABLED.

    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