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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCIBATINT(TM) TINTING PROCESS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCIBA VISION CARE
11460 JOHNS CREEK PKWY.
DULUTH, GA 30136-1518
PMA NumberP820086
Date Received12/20/1982
Decision Date02/08/1984
Withdrawal Date 06/05/2013
Product Code LPM 
Docket Number 84M-0091
Notice Date 04/10/1984
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S003 S004 S005 S006 S008 S010 S011 S012 
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