BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
FDA premarket approval P990027/S012 · decided 2009-06-26
Approval details
- PMA number
- P990027
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
- Generic name
- Excimer laser system
- Applicant
- Technolas Perfect Vision GmbH
- Date received
- 2009-05-15
- Decision date
- 2009-06-26
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- München
- Statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT TECHNOLAS PERFECTVISION GMBH, MUNICH, GERMANY.
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