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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(SENOFILCON A) BRAND CONTACT LENSES,VISTAKON(ETAFILCON A) BRAND CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
PMA NumberN18033
Supplement NumberS073
Date Received07/26/2013
Decision Date08/16/2013
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 
Add an alternate supplier for a component of the primary packaging.
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