PMA P990050S004
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S004
- Product code
- MOA
- Decision date
- 2002-06-14
- Classification
- Analyzer, Diagnostic, Fiber Optic (colon)
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Approval order statement
- APPROVAL FOR THE USE OF THE REUSABLE WAVSTAT OPTICAL BIOPSY FORCEPS WITH THE WAVSTAT OPTICAL BIOPSY SYSTEM.
Current openFDA PMA Record
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S004
- Product code
- MOA
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Decision date
- 2002-06-14
- Decision code
- APPR
- Date received
- 2001-12-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF THE REUSABLE WAVSTAT OPTICAL BIOPSY FORCEPS WITH THE WAVSTAT OPTICAL BIOPSY SYSTEM.