|
Device | WAVSTAT (TM) 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 | S003 |
Date Received | 09/17/2001 |
Decision Date | 11/28/2001 |
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 A NEW CONSOLE TO BE USED WITH THE OBS. THIS NEW CONSOLE CONSISTS OF A RECONFIGURATINO OF THE ORIGINAL CONSOLE AND INCORPORATES SEVERAL FEATURES INTENDED TO IMPROVE USABILITY OF THE DEVICE. |