BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Thermal Ablation, Endometrial

    PMA: P000032 · Supplement: S028 · Decision Mar 27, 2009
    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
    S028
    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
    March 27, 2009
    Date Received
    June 6, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE LABELING THE HER OPTION TO INCLUDE THE RESULTS OF THE CLINICAL STUDY CONDUCTED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE EXTENDED TREATMENT REGIMEN (ETR).

    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