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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOPTICAL BIOPSY(TM) SYSTEM
Generic NameANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
ApplicantSPECTRA SCIENCE
11568 SORRENTO VALLEY RD,SUITE
11
SAN DIEGO, CA 92121
PMA NumberP990050
Date Received08/24/1999
Decision Date11/14/2000
Product Code MOA 
Docket Number 01M-0478
Notice Date 10/19/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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