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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.
 
DeviceVISTAKON (ETAFILCON A) BRAND CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 CENTURION PKWY.
JACKSONVILLE, FL 32256
PMA NumberN18033
Supplement NumberS061
Date Received09/19/2011
Decision Date02/01/2012
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
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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