BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S094 · Decision Aug 28, 2023
    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
    S094
    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 28, 2023
    Date Received
    May 31, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the modification of the devices Remote Monitor to allow for the use of either a Tablet or Laptop. For the tablet interface the Remote Monitor uses Wi-Fi to communicate with the PDMS SW Application. The tablet can also receive updates remotely.

    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