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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.
Classification Nameanalyzer, diagnostic, fiber optic (colon)
Generic Nameanalyzer, diagnostic, fiber optic (colon)
PMA NumberP990050
Supplement NumberS002
Date Received07/20/2001
Decision Date08/17/2001
Product Code
MOA[ Registered Establishments with MOA ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the trade name of the device and related accessories to add the word "wavstat(tm)" to the beginning of the trade name. The device is indicated for use as an adjunct to lower gastrointestinal (gi) endoscopy. The device is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove. The device is only to be used in deciding whether such polyps should be removed (which includes submission for histological examination).