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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.
 
DeviceMiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses
Generic Namedaily wear soft contact lens to reduce the progression of myopia
ApplicantCooperVision, Inc.
5870 stoneridge drive
suite 1
pleasanton, CA 94588
PMA NumberP180035
Supplement NumberS002
Date Received01/09/2020
Decision Date02/04/2020
Product Code QIT 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacture of MiSight I Day lenses on Dry Line HC at the CooperVision Manufacturing, Ltd. facility in Chandlers Ford, United Kingdom.
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