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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLUMA CERVICAL IMAGING SYSTEM
Classification Namesensor,electro-optical(for cervical cancer)
Generic Nameoptical detection system (ods)
ApplicantMEDISPECTRA INC
PMA NumberP040028
Supplement NumberS001
Date Received03/20/2006
Decision Date04/11/2006
Product Code
MWM
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the incoming camera inspection test, test software used to assemble the luma system and the final test software used during burn-in.
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