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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 NumberS003
Date Received12/10/2007
Decision Date02/27/2009
Withdrawal Date 11/29/2010
Product Code MWM 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC. IN SAN DIEGO, CALIFORNIA.
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