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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceAIR, OPTIX, AQUA, MULTIFOCAL (lotrafilcon B) Soft Contact Lenses for daily and extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP010019
Supplement NumberS056
Date Received08/09/2017
Decision Date09/05/2017
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update to the device quality control testing by changing the in-process inspection of lens power, lens optical quality and lens diameter for AIR OPTIX AQUA MULTIFOCAL (lotrafilcon B) soft contact lenses.