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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.
 
DeviceMenicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni
Generic NameLens, contact, orthokeratology, overnight
ApplicantMenicon Co, Ltd.
21-19, Aoi 3-Chome, Naka-Ku
Nagoya 460-0006
PMA NumberP990018
Supplement NumberS008
Date Received02/07/2022
Decision Date08/02/2022
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
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 an expanded range of myopia treatment of up to 6.00 diopters (manifest spherical equivalent).
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