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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Nametisilfocon a rigid gas permeable contact lens
Regulation Number886.5916
ApplicantMENICON CO. LTD.
PMA NumberP990018
Supplement NumberS004
Date Received04/01/2009
Decision Date02/25/2010
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modified labeling to include information regarding the post-approval study.
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