AIR OPTIX FOR ASTIGMATISM
FDA premarket approval P010019/S011 · decided 2009-01-16
Approval details
- PMA number
- P010019
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AIR OPTIX FOR ASTIGMATISM
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2008-08-25
- Decision date
- 2009-01-16
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A CHANGE IN TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AIR OPTIX FOR ASTIGMATISM (LOTRAFILCON B) SOFT CONTACT LENSES.
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510(k) clearances by this applicant
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