BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S098 · Decision May 12, 2025
    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
    S098
    Device Class
    FDA Class 3
    Product Code
    PFN
    Generic Name
    Implanted brain stimulator for epilepsy
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 12, 2025
    Date Received
    March 7, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    new polyethylene bulk material from new supplier for the battery used within the RNS-320 system

    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