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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
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
7500 centurion parkway
suite 100 - erca
jacksonville, FL 32256
PMA NumberP040045
Supplement NumberS010
Date Received01/25/2010
Decision Date02/23/2010
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 Yes
Approval Order Statement 
ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR AN INERT DILUENT USED IN THE PRODUCTION OF THE DEVICE.
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