BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040003 · Supplement: S010 · Decision Dec 8, 2011
    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
    P040003
    Supplement Number
    S010
    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
    December 8, 2011
    Date Received
    September 13, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT.

    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