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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 drive
suite 1
pleasanton, CA 94588
PMA NumberP180035
Supplement NumberS004
Date Received01/15/2020
Decision Date07/12/2021
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
Approval Order Statement  
Approval of the protocol for the MiSight®1 Day Safety Post Approval Study (PAS) protocol.
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