BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Decision Jul 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    EXABLATE
    PMA Number
    P150038
    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 11, 2016
    Date Received
    October 21, 2015
    Expedited Review
    N
    Docket Number
    16M-2183

    Advisory Committee Statement

    Approval for the ExAblate Model 4000 Type 1.0 System (ExAblate Neuro). This device is indicated for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) 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