BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P970021 · Supplement: S002 · Decision Nov 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM
    PMA Number
    P970021
    Supplement Number
    S002
    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
    November 2, 1999
    Date Received
    February 3, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following modifications: 1) change in balloon material from latex to silicone; 2) addition of fluid circulation mechanism (i.e., impeller) within catheter; 3) change in software language from Assembly to a combination of C and Assembly; and 4) other minor modifications to the device system. In addition, changes also include a change in the manufacturer of the catheter controller to RELA, Inc., located at 410 S. Sunset, Bldg., D., Longmont, CO 80501. The device is intended 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