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

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S078 · Decision Jan 22, 2020
    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
    S078
    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
    January 22, 2020
    Date Received
    January 16, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Modify the PXI Vader automated test equipment (ATE) software, hardware, and test database to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320).

    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