BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S222 · Decision Feb 14, 2019
    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
    S222
    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 14, 2019
    Date Received
    January 15, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following labeling updates:1) Model 1000 (SN < 100,000) High Impedance Warning - the addition of a warning to the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding the potential for erroneous high impedance warning messages that can be received in certain Model 1000 Generators (i.e. Serial Number (SN) < 100,000); and2) Model 1000 (SN < 100,000) Package Insert: the creation of a package insert, containing the same warning information described above, that will be placed within the sales packaging of every Model 1000 Generator (SN < 100,000).

    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