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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
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 centurion pkwy.
jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS072
Date Received04/02/2013
Decision Date04/29/2013
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE THE QUALITY CONTROL SAMPLING PLAN FOR PACKAGE INTEGRITY TESTING OF VISTAKON BRAND CONTACT LENSES.
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