WAVSTAT OPTICAL BIOPSY SYSTEM
FDA premarket approval P990050/S006 · decided 2006-03-28
Approval details
- PMA number
- P990050
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WAVSTAT OPTICAL BIOPSY SYSTEM
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Applicant
- Spectra Science
- Date received
- 2005-07-19
- Decision date
- 2006-03-28
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.
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