BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P970021 · Decision Dec 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
    PMA Number
    P970021
    Device Class
    FDA Class 3
    Product Code
    MNB
    Generic Name
    Device, thermal ablation, endometrial
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 12, 1997
    Date Received
    June 17, 1997
    Expedited Review
    N
    Docket Number
    98M-0139

    Advisory Committee Statement

    Approval for the ThermaChoice(TM) Uterine Balloon Therapy(TM) UBT System. This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing 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