BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S037 · Decision Jul 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    Exablate Model 4000 Type-1 System
    PMA Number
    P150038
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    POH
    Generic Name
    MR-guided focused ultrasound system
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 3, 2025
    Date Received
    July 16, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    25M-2196

    Advisory Committee Statement

    The Exablate Neuro is intended indicated for use in the unilateral pallidothalamic tractotomy of advanced idiopathic Parkinson’s Disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinson’s disease medication treatment, and in the staged (by at least 6 months from the first pallidothalamic tractotomy), unilateral pallidothalamic tractotomy of idiopathic Parkinson’s Disease with medication-refractory motor complications of their contralateral side that was not previously treated in the first unilateral pallidothalamic tractotomy. Patients must be at least age 30. The designated area in the brain responsible for the motor complications symptoms (pallidothalamic tract) must be identified and accessible for targeted thermal ablation by the Exablate device.

    Classifications

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

    Product Code Device Name
    POH Mr-Guided Focused Ultrasound System