BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    PMA: P040003 · Supplement: S019 · Decision Oct 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
    Trade Name
    InSightec ExAblate System
    PMA Number
    P040003
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    NRZ
    Generic Name
    Ablation system, high intensity focused ultrasound (HIFU), MR-guided
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 28, 2016
    Date Received
    September 28, 2016
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of adenomyosis to the list of conditions for which the safety and effectiveness of ExAblate have not been evaluated.

    Classifications

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

    Product Code Device Name
    NRZ Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided