BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110039 · Decision Oct 18, 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
    PMA Number
    P110039
    Device Class
    FDA Class 3
    Product Code
    NRZ
    Generic Name
    Ablation system, high intensity focused ultrasound (HIFU), MR-guided
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 18, 2012
    Date Received
    December 5, 2011
    Expedited Review
    Y
    Docket Number
    12M-1085

    Advisory Committee Statement

    APPROVAL FOR THE EXABLATE SYSTEM, MODEL 2000/2100 /2100 VI. THIS DEVICE IS INDICATED FOR PAIN PALLIATION OF METASTATIC BONE CANCER IN PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE SUFFERING FROM BONE PAIN DUE TO METASTATIC DISEASE AND WHO ARC FAILURES OF STANDARD RADIATION THERAPY, OR NOT CANDIDATES FOR, OR REFUSED RADIATION THERAPY. THE BONE TUMOR TO BE TREATED MUST BE VISIBLE ON NON-CONTRAST MR AND DEVICE ACCESSIBLE.

    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