VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
FDA premarket approval P930016/S024 · decided 2006-05-03
Approval details
- PMA number
- P930016
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2006-03-30
- Decision date
- 2006-05-03
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR WAVESCAN SYSTEM SOFTWARE VERSION 3.70 CONTAINING MINOR DESIGN (USER INTERFACE AND STREAMLINED ACQUISITION AND TREATMENT PLANNING MODE) AND LABELING CHANGES.
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