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

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S095 · Decision Aug 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Brain Stimulator For Epilepsy
    Trade Name
    NeuroPace RNS System
    PMA Number
    P100026
    Supplement Number
    S095
    Device Class
    FDA Class 3
    Product Code
    PFN
    Generic Name
    Implanted brain stimulator for epilepsy
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 13, 2024
    Date Received
    July 15, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to implement supplier process changes at the Integer, which include introducing automation for the lubricant application during the initial part-forming step; and bringing in-house the previously outsourced annealing process, which the Integer originally developed, with no changes to the annealing recipe, tooling, materials, or specifications

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PFN Implanted Brain Stimulator For Epilepsy