PMA P990050S006
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S006
- Product code
- MOA
- Decision date
- 2006-03-28
- Classification
- Analyzer, Diagnostic, Fiber Optic (colon)
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.
Current openFDA PMA Record
- Device
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Applicant
- Spectra Science
- PMA number
- P990050
- Supplement
- S006
- Product code
- MOA
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Decision date
- 2006-03-28
- Decision code
- APPR
- Date received
- 2005-07-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.