BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S092 · Decision Feb 10, 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
    S092
    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
    February 10, 2023
    Date Received
    October 17, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a revised the RNS System Implanting and Programming Program Qualifications Questionnaire as follows:1) Provided a list of current diagnostic technologies utilized to identify the seizure onset;2) Clarified that qualified neurosurgeon(s) are ABNS board-certified or board-eligible and tracking toward certification, with experience in epilepsy surgery procedures and placement of intracranial electrodes;3) Specified that an established referral relationship is needed to ensure access to neuropsychological testing and mental health services; and4) Neurologist(s) who is American Board of Psychiatry and Neurology (ABPN) board- certified and is fellowship trained in epilepsy or in clinical neurophysiology, or has experience in the treatment of epilepsy, including selection of antiepileptic medications, interpretation of scalp and intracranial EEG, video EEG monitoring, and selection of patients for epilepsy surgery or neuromodulation devices.2. Revised the RNS System Programming Physician Qualifications Questionnaire as follows:1) At least one American Board of Psychiatry and Neurology (ABPN) board-certified neurologist with expertise in epilepsy and in the interpretation of EEG;2) Established referral relationship with Epilepsy Program qualified to implant and program the RNS System;3) Local access to urgent or emergent neurosurgical care; and4) Capability to provide instructions to patient and family members in RNS System use.

    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