VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM
FDA premarket approval P930016/S015 · decided 2002-08-07
Approval details
- PMA number
- P930016
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2002-07-30
- Decision date
- 2002-08-07
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN AUTO-CENTERING FUNCTION TO THE VISX STAR S4 ACTIVE TRAK EYE TRACKING SYSTEM THAT INCLUDES MINOR DESIGN AND LABELING CHANGES.
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