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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.
 
DeviceiWear oxygen and iWear oxygen astigmatism
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS058
Date Received03/27/2017
Decision Date05/05/2017
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling change to add new private label brand name, iWear oxygen and iWear oxygen astigmatism. The name iWear oxygen is intended for the spherical lenses and iWear oxygen astigmatism for the toric lenses.
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