BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S445 · Decision Sep 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Percept™ PC INS with BrainSense™ (Model B35200)
    PMA Number
    P960009
    Supplement Number
    S445
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 22, 2023
    Date Received
    December 22, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding a new requirement and new behavior to the firmware and changing the `Stim off Charge Pump Amplitude' from the maximum value to the minimum value. When stimulation is off, the Charge Pump will be set to the minimum value. Adding a new risk control measure and new behavior to the firmware. Every 5 minutes the firmware will now reset the Tel-N Phase Lock Loop (PLL). The interface and requirement will also be changed, and new behavior will be added to the firmware. When the relevant Tel-N command is received by the INS, the Tel-M module will be disabled for 5 seconds and then re-enabled. Fixing the cap balance routine configuration value to determine whether it was enabled. Updating so that a device with corrupt flash (with ECC errors) in the code space will be able to be updated over the air without causing an unexpected reset. Updating behavior so that stimulation will no longer lock up if the lead integrity test is canceled too soon. Updating a library code function that may cause a loss of data on the Serial Peripheral (SPI) bus if used. Updating behavior so group changes are always logged, even when therapy is off. INS behavior will also be changed so aDBS programs are applied correctly when the programs are enabled regardless of which aDBS program is reenabled first. Updating behavior so the Enable/disable aDBS program command works correctly and updates the settings for the sense group that was modified, but only applies the new settings to the runtime settings if the group whose settings were changed is the active group. Updating behavior so backup sensing settings are stored properly and reverting the settings works.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor