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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 (TM) OPTICAL BIOPSY SYSTEM
Generic NameANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
ApplicantSpectra Science
11568 Sorrento Valley Rd.
Suite 11
San Diego, CA 92121
PMA NumberP990050
Supplement NumberS003
Date Received09/17/2001
Decision Date11/28/2001
Product Code MOA 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW CONSOLE TO BE USED WITH THE OBS. THIS NEW CONSOLE CONSISTS OF A RECONFIGURATINO OF THE ORIGINAL CONSOLE AND INCORPORATES SEVERAL FEATURES INTENDED TO IMPROVE USABILITY OF THE DEVICE.
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