BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000032 · Supplement: S017 · Decision Feb 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    HER OPTION CRYOABLATION THERAPY SYSTEM
    PMA Number
    P000032
    Supplement Number
    S017
    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 16, 2006
    Date Received
    January 17, 2006
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE QUALITY TESTS USED TO EVALUATE THE THERMOCOUPLE WIRING IN THE DISPOSABLE CONTROL UNIT (DCU) AND FOR A CHANGE TO THE LABELING TO INCLUDE ADDITIONAL PRECAUTIONS/INSTRUCTIONS FOR THE YEAR.

    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