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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 (SENOFILCON A) CONTACT LENSES CLEAR/VISIBILITY TINTED WITH UV BLOCKER
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVistakon, Division of Johnson & Johnson Vision Car
7500 Centurion Pkwy.
Suite 100 - Erca
Jacksonville, FL 32256
PMA NumberP040045
Supplement NumberS007
Date Received06/22/2009
Decision Date02/19/2010
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE STABILITY PROTOCOL UTILIZED TO ESTABLISH SHELF-LIFE.
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