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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 NameVISTAKON (ETAFILCONA) CONTACT LENSES, CLEAR & VISIBILITY TINRED WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantVISTAKON
PMA NumberN18033
Supplement NumberS053
Date Received01/18/2011
Decision Date02/14/2011
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an alternate test method for determining the purity in the raw material, methacrylic acid, used in the vistakon® (etafilcon a) soft contact lenses.
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