WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68
FDA premarket approval P930016/S034 · decided 2011-03-04
Approval details
- PMA number
- P930016
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVESCAN WAVEFRONT SYSTEM SOFTWARE VERSION 3.68
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2010-09-20
- Decision date
- 2011-03-04
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR WAVESCAN WAVE- FRONT SOFTWARE VERSION 3.68.
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