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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameMODELS 019B, 019C, 019E, 019F, 019J, & 019K
Classification Nameintraocular lens
Generic Nameposterior chamber iols
Regulation Number886.3600
PMA NumberP810055
Date Received11/25/1981
Decision Date02/03/1983
Withdrawal Date 04/15/2009
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 83M-0047
Notice Date 02/25/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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