BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S100 · Decision Dec 19, 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 PERENNIAFLEX
    PMA Number
    P970003
    Supplement Number
    S100
    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
    December 19, 2008
    Date Received
    July 24, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVEDMODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"):1) CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVEFATIGUE RESISTANCE;2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE ANDABRASION RESISTANCE;3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALSO OFFERS NERVE COVERAGE >360 DEGREES.

    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