WAVSTAT OPTICAL BIOPSY SYSTEM
FDA premarket approval P990050/S007 · decided 2009-08-27
Approval details
- PMA number
- P990050
- Supplement
- S007
- Supplement type
- Real-Time Process
- 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
- 2009-06-30
- Decision date
- 2009-08-27
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES DUE TO THE HARDWARE PARTS¿ OBSOLESCENCE, MINOR LABELING CHANGES TO REFLECT THE CHANGES IN THE HARDWARE, AND A SOFTWARE CHANGE TO UPDATE THE OPERATING SYSTEM.
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