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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 (ETAFILCON A) BRAND CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantVISTAKON
PMA NumberN18033
Supplement NumberS061
Date Received09/19/2011
Decision Date02/01/2012
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the implementation of an alternate test method for determining the purity of the raw materials used in reactive monomer mix formulation.
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