BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S026 · Decision Mar 25, 2025
    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 Systems (“Exablate Neuro”)
    PMA Number
    P150038
    Supplement Number
    S026
    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
    March 25, 2025
    Date Received
    April 11, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change to the prescriber’s labeling to include the post-approval study (PAS) results from the 5-year follow-up of the continued access cohort (ET002-CA) evaluated under investigational device exemption (IDE) G120246/S007 to continue use of the Exablate Neuro while the original PMA P150038 application was being reviewed by the FDA

    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