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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 NumberS005
Date Received02/07/2002
Decision Date08/06/2002
Product Code MOA 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE WAVSTAT OPTICAL BIOPSY SYSTEM (OBS) TO BE EXTENDED TO INCLUDE THE WAVSTAT OPTICAL BIOPSY SYSTEM MODEL III CONSOLE.
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