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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.
 
DeviceSofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS144
Date Received04/01/2022
Decision Date08/15/2022
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear: Sofmed breathables XW Extended Parameters and Sofmed breathables XW toric Extended Parameters.
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