BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P970021 · Supplement: S028 · Decision May 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM
    PMA Number
    P970021
    Supplement Number
    S028
    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
    May 13, 2010
    Date Received
    November 20, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATED PROFESSIONAL LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY REQUIRED AS A CONDITION OF APPROVAL TO SUPPLEMENT 14.

    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