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

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S074 · Decision Aug 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Brain Stimulator For Epilepsy
    Trade Name
    NeuroPac RNS System
    PMA Number
    P100026
    Supplement Number
    S074
    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 26, 2019
    Date Received
    August 15, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of an alternate laser welder, the IPG Laser Weld System, to perform laser welding on the RNS Neurostimulator during manufacturing operations at NeuroPace (455 N. Bernardo Ave. Mountain, California).

    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