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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.
 
DeviceMODELS 019B, 019C, 019E, 019F, 019J, & 019K
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 E. ST. ANDREW PLACE
P.O. BOX 25162
SANTA ANA, CA 92705-4933
PMA NumberP810055
Date Received11/25/1981
Decision Date02/03/1983
Withdrawal Date 04/15/2009
Product Code HQL 
Docket Number 83M-0047
Notice Date 02/25/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S003 S004 S005 S006 S008 S010 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S037 S038 S039 S040 S041 
S042 S043 S044 S047 S050 S051 S052 S053 S054 S055 S056 S057 
S058 S059 S061 S063 S066 S067 S068 S069 S070 S071 S072 
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