PMA P990050S003
- Device
- WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S003
- Product code
- MOA
- Decision date
- 2001-11-28
- Classification
- Analyzer, Diagnostic, Fiber Optic (colon)
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- 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.
Current openFDA PMA Record#
- Device
- WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S003
- Product code
- MOA
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Decision date
- 2001-11-28
- Decision code
- APPR
- Date received
- 2001-09-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.