VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
FDA premarket approval P930016/S026 · decided 2006-11-03
Approval details
- PMA number
- P930016
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2006-10-24
- Decision date
- 2006-11-03
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR AN UPGRADE OF THE WAVESCAN SOFTWARE TO VERSION 3.67 TO CORRECT A DESIGN FLAW THAT LED TO AN INCORRECT PATIENT TREATMENT BEING DELIVERED, AND TO INTRODUCE AN ADDITIONAL SOFTWARE CHECK TO MITIGATE TREATMENT CALCULATION ERRORS.
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