BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P230002 · Decision Jul 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    Minitouch 3.8 Era System (Minitouch System)
    PMA Number
    P230002
    Device Class
    FDA Class 3
    Product Code
    MNB
    Generic Name
    Device, thermal ablation, endometrial
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 28, 2023
    Date Received
    January 30, 2023
    Expedited Review
    N
    Docket Number
    23M-3222

    Advisory Committee Statement

    Approval for the Minitouch 3.8 Era System (Minitouch System). This device is indicated for ablation of the endometrial lining of the uterus for the treatment of menorrhagia (heavy menstrual bleeding) due to benign causes in premenopausal women for whom childbearing is complete.

    Classifications

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

    Product Code Device Name
    MNB Device, Thermal Ablation, Endometrial