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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) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
PMA NumberP040045
Supplement NumberS014
Date Received06/28/2010
Decision Date11/18/2010
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the implementation of an alternate method for visual inspection of raw materials for vistakon® (senofilcona) contact lenses, clear and visibility tinted with uv blocker.
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