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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.
 
DeviceLOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR, O2 OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM,AIR OPTIX AQUA
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP010019
Supplement NumberS036
Date Received11/12/2013
Decision Date12/05/2013
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
TRANSITION FROM A SEMI-AUTOMATED TO A FULLY AUTOMATEDMANUFACTURING PROCESS.
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