OPTICAL BIOPSY(TM) SYSTEM
FDA premarket approval P990050/S001 · decided 2001-02-16
Approval details
- PMA number
- P990050
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTICAL BIOPSY(TM) SYSTEM
- Generic name
- ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
- Applicant
- Spectra Science
- Date received
- 2001-01-25
- Decision date
- 2001-02-16
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MOA
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR TWO ADDITIONAL WORKING LENGTHS OF OPTICAL FIBERS TO BE INCLUDED WITH THE OPTICAL BIOPSY(TM) SYSTEM.
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