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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.
 
DeviceCERVICAL IMAGING SYSTEM
Generic NameSensor, electro-optical (for cervical cancer)
ApplicantSPECTRA SCIENCE
11568 SORRENTO VALLEY RD
SUITE 11
SAN DIEGO, CA 92121
PMA NumberP040028
Supplement NumberS004
Date Received02/10/2009
Decision Date03/19/2009
Withdrawal Date 11/29/2010
Product Code MWM 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE LUMA PROBE COVER FROM TWO YEARS TO THREE YEARS.
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