BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P150031 · Supplement: S068 · Decision May 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
    PMA Number
    P150031
    Supplement Number
    S068
    Device Class
    FDA Class 3
    Product Code
    NHL
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian symptoms
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 14, 2024
    Date Received
    December 5, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    This updated software version only includes the enabling of the DBS Illumina 3D programming feature. All other VNN5 software functions and controls in place for programming the stimulation parameters into the implanted device and for delivering the stimulation via the implanted electrodes remain the same as the previously approved software version. The DBS Illumina 3D programming feature does not replace the need for clinical judgment in determining and finalizing the stimulation parameters that will be clinically effective for the patient, which remains the same as the previously approved software version. The device labeling has been updated with the following changes:- The VNN5 Programming Manual was updated to include the new VNN5 software version number and include instructions specific to the use of the DBS Illumina 3D programming feature.- The Clinician Programmer (CP) Software Installation Guide was updated to remove any specific mention of VNN5, thereby making the instructions more general to installing any software that will be used with the Clinician Programmer.- The DBS Reference Guide was updated to include the new VNN5 software version number and updating the document reference for the new CP Software Installation Guide.- A new Virtual Label was created for VNN5.0.1 to reflect the new software version number.

    Classifications

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

    Product Code Device Name
    NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms