BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S034 · Decision Feb 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    Exablate
    PMA Number
    P150038
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    POH
    Generic Name
    MR-guided focused ultrasound system
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 27, 2024
    Date Received
    January 29, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change of the manufacturing method for the head membrane rings from computer numerical control (CNC) machining to molding, and the manufacturing method of attaching the rings to head membrane was changed from screws to over-molding

    Classifications

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

    Product Code Device Name
    POH Mr-Guided Focused Ultrasound System