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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
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
Applicant
MENICON CO. LTD.
269 a ballardvale street
wilmington, MA 01887
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 change - pas
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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