BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000040 · Supplement: S013 · Decision May 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    HTA SYSTEM
    PMA Number
    P000040
    Supplement Number
    S013
    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
    May 14, 2009
    Date Received
    February 13, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE HTA PROCEDURE SHEATH (A COMPONENT OF THE HTA SYSTEM) WHICH INCLUDE THE ADDITION OF THE CERVICAL SEAL ASSIST COMPONENT AND A REDESIGN OF THE RESERVOIR TIP. THE SHEATH, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTA PROCERVA PROCEDURE SHEATH.

    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