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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameanalyzer, diagnostic, fiber optic (colon)
Generic Nameanalyzer, diagnostic, fiber optic (colon)
11568 sorrento valley rd,suite
san diego, CA 92121
PMA NumberP990050
Date Received08/24/1999
Decision Date11/14/2000
Product Code
MOA[ Registered Establishments with MOA ]
Docket Number 01M-0478
Notice Date 10/19/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the optical biopsy(tm) system. 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).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007