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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 Aichi 460-0-0006
PMA NumberP990018
Supplement NumberS009
Date Received01/31/2023
Decision Date05/01/2023
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for lens parameters ranges for the central base curve radius, tangential angle and sagittal depth.
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