BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000032 · Supplement: S025 · Decision Jul 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Device, Thermal Ablation, Endometrial
    Trade Name
    HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
    PMA Number
    P000032
    Supplement Number
    S025
    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 16, 2008
    Date Received
    February 6, 2008
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRANSFER OF THE DEWAR ASSEMBLY COMPONENT PROCUREMENT, INCOMING RECEIVING AND INSPECTION, AND SUB-ASSEMBLY ACTIVITIES, INCLUDING MACHINE GRIND AND NITROGEN TESTING, FROM AMERICAN MEDICAL SYSTEMS TO JOINING TECHNOLOGIES.

    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