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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.
 
DeviceACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management
Generic NameLens, contact, orthokeratology, overnight
ApplicantMenicon Co, Ltd.
21-19, Aoi 3-Chome, Naka-Ku
Nagoya 460-0006
PMA NumberP990018
Supplement NumberS006
Date Received01/21/2021
Decision Date05/06/2021
Product Codes NUU MWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of the following private label trade names for the Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear: ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management.
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