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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.
 
DeviceCELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantALCON LABORATORIES
6201 South Freeway
Fort Worth, TX 76134
PMA NumberP990023
Date Received05/07/1999
Decision Date02/24/2000
Product Code LZP 
Docket Number 00M-0809
Notice Date 08/03/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 
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