BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S070 · Decision Aug 1, 2019
    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
    S070
    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
    August 1, 2019
    Date Received
    June 3, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following protocol changes and associated changes to data collection and informed consent forms:1) Increase the upper limit on the number of subjects that can be implanted per study site;2) Simplify the text to remove references to activities that are not study-specific (i.e. are standard in the management of the RNS System);3) Revise inclusion/exclusion criteria to only include study-specific criteria;4) Add the option of phone appointments for specific follow-up time points; and5) Minor clarifications and administrative changes. for the post-approval studies (PAS) protocol.

    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