BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ultrasound, Hyperthermia, Cancer Treatment

    PMA: P040003 · Supplement: S001 · Decision Dec 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Ultrasound, Hyperthermia, Cancer Treatment
    Trade Name
    EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM
    PMA Number
    P040003
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LSY
    Generic Name
    Ultrasound, hyperthermia, cancer treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 30, 2005
    Date Received
    August 25, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT INSIGHTEC IMAGE GUIDED TREATMENT LTD., TIRAT CARMEL, ISRAEL.

    Classifications

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

    Product Code Device Name
    LSY Ultrasound, Hyperthermia, Cancer Treatment