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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 NumberS001
Date Received03/20/2006
Decision Date04/11/2006
Withdrawal Date11/29/2010
Product Code MWM 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATIONS TO THE INCOMING CAMERA INSPECTION TEST, TEST SOFTWARE USED TO ASSEMBLE THE LUMA SYSTEM AND THE FINAL TEST SOFTWARE USED DURING BURN-IN.
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