BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000040 · Supplement: S001 · Decision Jul 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM
    PMA Number
    P000040
    Supplement Number
    S001
    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
    July 10, 2001
    Date Received
    June 18, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUFACTURING CHANGES TO THE PHYSICAL STRUCTURE OF THE HYDRO THERMABLATOR(R) UNIT.

    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