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Device | OPTICAL BIOPSY(TM) SYSTEM |
Generic Name | ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON) |
Applicant | SPECTRA SCIENCE 11568 SORRENTO VALLEY RD,SUITE 11 SAN DIEGO, CA 92121 |
PMA Number | P990050 |
Date Received | 08/24/1999 |
Decision Date | 11/14/2000 |
Product Code |
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
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 |