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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
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
PMA NumberP040045
Supplement NumberS025
Date Received09/12/2011
Decision Date10/12/2011
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Upgrade to the saline dose head during the manufacturing of the device.
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