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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) Contact Lenses for Daily Wear
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 NumberS031
Date Received08/27/2025
Decision Date10/28/2025
Product Code QIT 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of protocol changes to enroll approximately 1000 subjects in PAS002 to achieve at least 4000 patient years total (approximately 2000 per study) with an average follow up of 2-3 years per subject. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180035.
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