|Trade Name||WAVSTAT OPTICAL BIOPSY SYTEM|
|Classification Name||analyzer, diagnostic, fiber optic (colon)|
|Generic Name||analyzer, diagnostic, fiber optic (colon)|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| 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).