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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS002
Date Received06/12/2006
Decision Date06/26/2006
Withdrawal Date11/29/2010
Product Code MWM 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TWO ADDITIONAL INTEGRITY VERIFICATION TESTS.
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