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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameWAVSTAT OPTICAL BIOPSY SYSTEM
Classification Nameanalyzer, diagnostic, fiber optic (colon)
Generic Nameanalyzer, diagnostic, fiber optic (colon)
ApplicantSPECTRASCIENCE, INC.
PMA NumberP990050
Supplement NumberS007
Date Received06/30/2009
Decision Date08/27/2009
Product Code
MOA[ Registered Establishments with MOA ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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