BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040003 · Supplement: S005 · Decision Mar 4, 2009
    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 2000 SYSTEM
    PMA Number
    P040003
    Supplement Number
    S005
    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
    March 4, 2009
    Date Received
    September 19, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING AND TREATMENT PROTOCOL CHANGES. THE DEVICE, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME EXABLATE 2000 AND IS INDICATED FOR ABLATION OF UTERINE FIBROID TISSUE IN PRE-OR PERI-MENOPAUSAL WOMEN WITH SYMPTOMATIC UTERINE FIBROIDS WHO DESIRE A UTERINE SPARING PROCEDURE AND WHOSE UTERINE SIZE IS LESS THAN 24 WEEKS. LIMITED INFORMATION IS AVAILABLE REGARDING THE SAFETY AND EFFECTIVENESS OF THE EXABLATE AS A TREATMENT FOR WOMEN WHO DESIRE PREGNANCY. PATIENTS SHOULD HAVE COMPLETED CHILD BEARING.

    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