PMA P990050S001
- Device
- OPTICAL BIOPSY(TM) SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S001
- Product code
- MOA
- Decision date
- 2001-02-16
- Classification
- Analyzer, Diagnostic, Fiber Optic (colon)
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Approval order statement
- APPROVAL FOR TWO ADDITIONAL WORKING LENGTHS OF OPTICAL FIBERS TO BE INCLUDED WITH THE OPTICAL BIOPSY(TM) SYSTEM.
Current openFDA PMA Record
- Device
- OPTICAL BIOPSY(TM) SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S001
- Product code
- MOA
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Decision date
- 2001-02-16
- Decision code
- APPR
- Date received
- 2001-01-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO ADDITIONAL WORKING LENGTHS OF OPTICAL FIBERS TO BE INCLUDED WITH THE OPTICAL BIOPSY(TM) SYSTEM.