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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 NameFRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namesoft (hydrophilic) contact lens
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP830037
Supplement NumberS053
Date Received09/23/2011
Decision Date02/07/2012
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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