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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 A) RIGID GAS PERMEABLE CONTACT LENS
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantMENICON CO. LTD.
21-19, Aoi 3-Chome, Naka-ku
Nagoya Aichi 460-0-0006
PMA NumberP990018
Supplement NumberS004
Date Received04/01/2009
Decision Date02/25/2010
Product Code MWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFIED LABELING TO INCLUDE INFORMATION REGARDING THE POST-APPROVAL STUDY.
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