BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000040 · 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
    HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
    PMA Number
    P000040
    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
    April 20, 2001
    Date Received
    September 25, 2000
    Expedited Review
    N
    Docket Number
    01M-0578

    Advisory Committee Statement

    APPROVAL FOR THE HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM. THE DEVICE IS INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES 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