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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)
Generic NameDaily wear soft contact lens to reduce the progression of myopia
ApplicantCooperVision, Inc.
5870 Stoneridge Dr., Suite 1
Pleasanton, CA 94588
PMA NumberP180035
Supplement NumberS016
Date Received03/03/2023
Decision Date03/22/2023
Product Code QIT 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Introduction of a new high volume impression strip blister tool.
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