BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P010013 · Supplement: S067 · Decision Jan 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
    PMA Number
    P010013
    Supplement Number
    S067
    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
    January 10, 2017
    Date Received
    August 1, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design modifications to the NovaSure Disposable Device (Gen 4.1).

    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