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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 (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight
Generic NameLens, contact (rigid gas permeable), extended wear
ApplicantMenicon Co, Ltd.
21-19, Aoi 3-Chome, Naka-Ku
Nagoya 460-0006
PMA NumberP990018
Supplement NumberS007
Date Received07/16/2021
Decision Date11/16/2022
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for incorporation of a listed color additive for tisilfocon A, an alternative wet shipping solution for Menicon Z Night, shelf-life changes for Menicon Z Night, polymer specification changes for tisilfocon A, and labeling changes for Menicon Z EW and Menicon Z Night.
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