BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S074 · Decision Oct 31, 2006
    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
    S074
    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
    October 31, 2006
    Date Received
    October 10, 2006
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A PRECAUTION TO THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.6.1 AND MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.0 IN THREE DIFFERENT PLACES IN EACH OF THE RESPECTIVE MANUALS.

    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