PMA P990050S005
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S005
- Product code
- MOA
- Decision date
- 2002-08-06
- Classification
- Analyzer, Diagnostic, Fiber Optic (colon)
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Approval order statement
- APPROVAL FOR THE WAVSTAT OPTICAL BIOPSY SYSTEM (OBS) TO BE EXTENDED TO INCLUDE THE WAVSTAT OPTICAL BIOPSY SYSTEM MODEL III CONSOLE.
Current openFDA PMA Record
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S005
- Product code
- MOA
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Decision date
- 2002-08-06
- Decision code
- APPR
- Date received
- 2002-02-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE WAVSTAT OPTICAL BIOPSY SYSTEM (OBS) TO BE EXTENDED TO INCLUDE THE WAVSTAT OPTICAL BIOPSY SYSTEM MODEL III CONSOLE.