BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Sensor, Electro-Optical (For Cervical Cancer)

    PMA: P040028 · Decision Mar 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sensor, Electro-Optical (For Cervical Cancer)
    Trade Name
    LUMA CERVICAL IMAGING SYSTEM
    PMA Number
    P040028
    Device Class
    FDA Class 3
    Product Code
    MWM
    Generic Name
    Sensor, electro-optical (for cervical cancer)
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 16, 2006
    Date Received
    June 18, 2004
    Expedited Review
    Y
    Docket Number
    06M-0148

    Advisory Committee Statement

    APPROVAL FOR THE LUMA CERVICAL IMAGING SYSTEM. THE DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO COLPOSCOPY FOR THE IDENTIFICATION OF HIGH-GRADE DISEASE (CIN 2, 3+) IN WOMEN REFERRED TO COLPOSCOPY WITH A PAP TEST RESULT OF ATYPICAL SQUAMOUS CELLS (ASC), LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESION (LSIL) OR HIGH-GRADE SQUAMOUS INTRAEPITHELIAL LESION OR CANCER (HSIL+).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWM Sensor, Electro-Optical (For Cervical Cancer)