BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040003 · Supplement: S011 · Decision May 1, 2012
    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
    EXABLATE DEVICE
    PMA Number
    P040003
    Supplement Number
    S011
    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
    May 1, 2012
    Date Received
    April 9, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES INCLUDING: 1) DELETION OF THE COMMENT (OUTCOMES OF 10 PREGNANCIES ARE PENDING AS OF AUGUST 2008, AND OUTCOME OF ONE PREGNANCY IS UNKNOWN.) AND ADDITION OF DEEP VEIN THROMBOSIS UNDER THE SECTION ENTITLED OTHER ADVERSE EVENTS.

    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