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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.
 
DeviceFRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP830037
Supplement NumberS053
Date Received09/23/2011
Decision Date02/07/2012
Withdrawal Date02/27/2019
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE THE NEW PHOENIX VT PRINT PADS USED TO TRANSFER INKS ONTO THE LENS SURFACE AND FOR THE ADDITION OF A PRE-CONDITIONING STEP FOR OPTIMAL INK ADHESION ONTO THE LENSES WHEN THE NEW PRINT PAD IS UTILIZED.
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