WAVSTAT OPTICAL BIOPSY SYSTEM
FDA premarket approval P990050/S004 · decided 2002-06-14
Approval details
- PMA number
- P990050
- Supplement
- S004
- 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
- 2001-12-17
- Decision date
- 2002-06-14
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE USE OF THE REUSABLE WAVSTAT OPTICAL BIOPSY FORCEPS WITH THE WAVSTAT OPTICAL BIOPSY SYSTEM.
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