BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S085 · Decision May 24, 2021
    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
    S085
    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 24, 2021
    Date Received
    February 23, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor updates to the RNS® Tablet. NeuroPace is requesting approval for addition of Mobile Device Management (MDM) capability on the tablet platform as well as changes to the login requirements for accessing the NeuroPace Programmer Application on the tablet.

    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