WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
FDA premarket approval P990050/S003 · decided 2001-11-28
Approval details
- PMA number
- P990050
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Applicant
- Spectra Science
- Date received
- 2001-09-17
- Decision date
- 2001-11-28
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- MOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR A NEW CONSOLE TO BE USED WITH THE OBS. THIS NEW CONSOLE CONSISTS OF A RECONFIGURATINO OF THE ORIGINAL CONSOLE AND INCORPORATES SEVERAL FEATURES INTENDED TO IMPROVE USABILITY OF THE DEVICE.
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