BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S214 · Decision Dec 27, 2017
    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
    S214
    Device Class
    FDA Class 3
    Product Code
    LYJ
    Generic Name
    STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 27, 2017
    Date Received
    November 20, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the Leads Manufacturing Process to add the following two (2) processes on all commercially available Lead Models (302/303/304):1) Additional use of the currently approved primer; proposed application to the Suture and along the exposed edge of the Electrode; and2) Implementation of a Protection Aid to encapsulate the Lead Helicals, protecting them from Ribbon Damage during further processing steps. This will be removed at the end of the Lead Final assembly.

    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