BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S022 · Decision Dec 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)
    PMA Number
    P150038
    Supplement Number
    S022
    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
    December 8, 2022
    Date Received
    June 14, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes to the indications for use of the device in idiopathic Essential tremor patients with medication-refractory tremor.

    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