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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Generic Namedaily wear soft contact lens to reduce the progression of myopia
Applicant
CooperVision, Inc.
5870 stoneridge drive
suite 1
pleasanton, CA 94588
PMA NumberP180035
Date Received09/04/2018
Decision Date11/15/2019
Product Code QIT 
Docket Number 19M-5438
Notice Date 11/19/2019
Advisory Committee Ophthalmic
Clinical Trials NCT01729208
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear. This device indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with less than or equal to 0.75 diopters of astigmatism. The lens is to be discarded after each removal.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S005 
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