BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P010013 · Supplement: S041 · Decision Feb 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
    PMA Number
    P010013
    Supplement Number
    S041
    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
    February 1, 2013
    Date Received
    September 7, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF LABELING CHANGES PERTAINING TO THE USE OF NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION IN PATIENTS WHO HAVE MICRO-INSERTS FROM THE ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL TRAILING INTO THE ENDOMETRIAL CAVITY FROM THE FALLOPIAN TUBES.

    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