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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 Date11/29/2010
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
Predetermined Change Control Plan AuthorizedNo
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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