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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAIR OPTIX FOR ASTIGMATISM
Classification Namelenses, soft contact, extended wear
Generic Nameextended wear soft contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP010019
Supplement NumberS011
Date Received08/25/2008
Decision Date01/16/2009
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order 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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