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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 SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namecontact lens (rigid gas permeable) extended wear
Regulation Number886.5916
ApplicantMENICON CO. LTD.
PMA NumberP880098
Supplement NumberS012
Date Received11/19/2002
Decision Date12/10/2002
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alcon unique-ph multi-purpose solution as an alternate wet shipping solution for the menicon sf-p rigid gas permeable contact lens, labeling changes to reflect the use of alcon unique-ph as a packaging solution and to update the labeling in accordance with recently approved menicon rigid gas permeable contact lens labeling.
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