WAVSTAT OPTICAL BIOPSY SYSTEM
FDA premarket approval P990050/S005 · decided 2002-08-06
Approval details
- PMA number
- P990050
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Applicant
- Spectra Science
- Date received
- 2002-02-07
- Decision date
- 2002-08-06
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE WAVSTAT OPTICAL BIOPSY SYSTEM (OBS) TO BE EXTENDED TO INCLUDE THE WAVSTAT OPTICAL BIOPSY SYSTEM MODEL III CONSOLE.
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