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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.
 
DeviceMODEL AC-21 OMNIFIT ANTERIOR CHAMBER
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 e. st. andrew place
p.o. box 25162
santa ana, CA 92705-4933
PMA NumberP860034
Date Received01/20/1984
Decision Date09/29/1989
Withdrawal Date 11/20/2006
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 89M-0425
Notice Date 11/13/1989
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S007 S008 S009 S010 S011 S012 S013 S014 S015 
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