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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 NameLOTRAFILCON A & LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Nameextended wear soft contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP010019
Supplement NumberS023
Date Received04/13/2011
Decision Date05/11/2011
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 
Raw material test method change.
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