PMA P990050S007
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S007
- Product code
- MOA
- Decision date
- 2009-08-27
- Classification
- Analyzer, Diagnostic, Fiber Optic (colon)
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- 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.
Current openFDA PMA Record
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S007
- Product code
- MOA
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Decision date
- 2009-08-27
- Decision code
- APPR
- Date received
- 2009-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.