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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 plus HYDRAGLYDE Soft Contact Lenses for Daily and Extended Wear
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP010019
Supplement NumberS054
Date Received03/24/2017
Decision Date04/21/2017
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Update to the variable sampling plan for the lens power testing during in-process and final product quality control testing of AIR OPTIX plus HydraGlyde (lotrafilcon B) soft contact lenses for daily and extended wear.
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