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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.
 
DevicePearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS049
Date Received09/27/2016
Decision Date03/10/2017
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  
Approved for Cooper Vision comfilcon A soft extended wear contact lenses to add a new private label name Pearl Vision Monthly and Pearl Vision Monthly for Astigatism.
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