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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLUMA CERVICAL IMAGING SYSTEM
Generic NameSensor, electro-optical (for cervical cancer)
ApplicantSPECTRA SCIENCE
11568 SORRENTO VALLEY RD
SUITE 11
SAN DIEGO, CA 92121
PMA NumberP040028
Date Received06/18/2004
Decision Date03/16/2006
Withdrawal Date 11/29/2010
Product Code MWM 
Docket Number 06M-0148
Notice Date 04/12/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order 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+).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 
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