Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | WAVSTAT OPTICAL BIOPSY SYSTEM |
Generic Name | ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON) |
Applicant | SPECTRA SCIENCE 11568 SORRENTO VALLEY RD,SUITE 11 SAN DIEGO, CA 92121 |
PMA Number | P990050 |
Supplement Number | S007 |
Date Received | 06/30/2009 |
Decision Date | 08/27/2009 |
Product Code |
MOA |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR DESIGN CHANGES DUE TO THE HARDWARE PARTS¿ OBSOLESCENCE, MINOR LABELING CHANGES TO REFLECT THE CHANGES IN THE HARDWARE, AND A SOFTWARE CHANGE TO UPDATE THE OPERATING SYSTEM. |
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