BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implanted Brain Stimulator For Epilepsy

    PMA: P100026 · Supplement: S056 · Decision Aug 1, 2018
    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
    S056
    Device Class
    FDA Class 3
    Product Code
    PFN
    Generic Name
    Implanted brain stimulator for epilepsy
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 1, 2018
    Date Received
    July 3, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Modify the PXI Vader automated test equipment (ATE) power-up software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuitry (Cassandra) and printed circuit assembly (PCA) testing. Additionally, the Dog Tag test limits for the integrated circuit are being modified in the PXI Vader ATE, Telemetry Only System (TOS) ATE and the PXI Vader Temperature ATE databases to allow flexibility to also test future integrated circuits for product development purposes.

    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