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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 NumberS002
Date Received06/12/2006
Decision Date06/26/2006
Product Code
MWM
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two additional integrity verification tests.
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