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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® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
Generic NameLens, contact (rigid gas permeable), extended wear
ApplicantMenicon Co, Ltd.
21-19, Aoi 3-Chome, Naka-Ku
Nagoya 460-0006
PMA NumberP990018
Supplement NumberS010
Date Received05/23/2023
Decision Date06/16/2023
Product Codes MWL NUU 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changing the manufacturing site for the lens blank material.
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