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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 PARKWAY
SUITE 100 - ERCA
JACKSONVILLE, FL 32256
PMA NumberP040045
Supplement NumberS015
Date Received08/23/2010
Decision Date09/24/2010
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
CHANGE TO THE OXYGEN PERMEABILITY TEST METHOD TM-0534.
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