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

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    PMA: P970003 · Supplement: S243 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stimulator, Autonomic Nerve, Implanted For Epilepsy
    Trade Name
    SenTiva™ Generator, SenTiva Duo™ Generator
    PMA Number
    P970003
    Supplement Number
    S243
    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
    March 15, 2024
    Date Received
    February 15, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to automate the dimensional inspections using the Keyence LM-1100 Image Dimension Measuring System during the receiving inspection for the VNS Therapy devices

    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