BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Deep Brain Stimulation For The Treatment Of Dystonia

    PMA: P960009 · Supplement: S482 · Decision Nov 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Deep Brain Stimulation For The Treatment Of Dystonia
    Trade Name
    Medtronic DBS Therapy for Dystonia
    PMA Number
    P960009
    Supplement Number
    S482
    Device Class
    FDA Class 3
    Product Code
    SGS
    Generic Name
    Deep Brain Stimulation for the treatment of Dystonia
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 22, 2025
    Date Received
    June 6, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    25M-6405

    Advisory Committee Statement

    Approval for expanding the indications for use to include the following: Bilateral stimulation of the internal globus pallidus (GPi) using Medtronic DBS therapy for Dystonia is indicated as an aid in the management of chronic, intractable (oral and/or injectable medication refractory) primary dystonia, including: 1) generalized dystonia, segmental dystonia of the head and neck, and cervical dystonia (torticollis) in adult patients; and 2) generalized dystonia in pediatric patients twelve years of age or above

    Classifications

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

    Product Code Device Name
    SGS Deep Brain Stimulation For The Treatment Of Dystonia