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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000032 · Decision Apr 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
    PMA Number
    P000032
    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    Approved (Withdrawn)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
    April 20, 2001
    Date Received
    July 27, 2000
    Expedited Review
    N
    Docket Number
    01M-0412

    Advisory Committee Statement

    APPROVAL FOR THE HEROPTION(TM) UTERINE CRYOBLATION THERAPY(TM) SYSTEM. THE DEVICE IS A CLOSED-CYCLE CRYOSURGICAL DEVICE INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES 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