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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.
 
DeviceWAVSTAT OPTICAL BIOPSY SYSTEM
Generic NameANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
ApplicantSPECTRA SCIENCE
11568 SORRENTO VALLEY RD,SUITE
11
SAN DIEGO, CA 92121
PMA NumberP990050
Supplement NumberS007
Date Received06/30/2009
Decision Date08/27/2009
Product Code MOA 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES DUE TO THE HARDWARE PARTS¿ OBSOLESCENCE, MINOR LABELING CHANGES TO REFLECT THE CHANGES IN THE HARDWARE, AND A SOFTWARE CHANGE TO UPDATE THE OPERATING SYSTEM.
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