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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
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantMenicon Co, Ltd.
21-19, Aoi 3-Chome, Naka-Ku
Nagoya 460-0-0006
PMA NumberP990018
Supplement NumberS005
Date Received11/28/2018
Decision Date11/06/2019
Product Code 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 manufacture, market and distribute overnight orthokeratology contact lenses from the Menicon Z (tisilfocon A) rigid gas permeable contact lens material.
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