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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesensor,electro-optical(for cervical cancer)
Generic Namesensor,electro-optical(for cervical cancer)
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
Docket Number 06M-0148
Notice Date 04/12/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004