BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P960009 · Supplement: S478 · Decision Feb 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System
    PMA Number
    P960009
    Supplement Number
    S478
    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
    February 20, 2025
    Date Received
    April 17, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    25M-0480

    Advisory Committee Statement

    for a new optional programming feature called adaptive deep brain stimulation (aDBS). This device is indicated for bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years’ duration that are not adequately controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications of longer-standing duration.

    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