BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S014 · Decision Oct 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
    PMA Number
    P150038
    Supplement Number
    S014
    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
    October 29, 2021
    Date Received
    March 31, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    21M-1182

    Advisory Committee Statement

    Approval for the Exablate Neuro. The device is indicated for use in the unilateral pallidotomy of patients with advanced, idiopathic Parkinsons disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinsons disease medication treatment. Patients must be at least age 30. The designated area in the brain responsible for the movement disorder symptoms [globus pallidus (GPi)] 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