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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.
 
DeviceSENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP980040
Date Received10/01/1998
Decision Date02/03/2000
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 00M=0445
Notice Date 02/16/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the amo® sensar™ soft acrylic, uv light-absorbing, posterior chamber intraocular lens (iol), model ar40. This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S032 S033 S034 S035 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 
S058 S059 S060 S061 S062 S063 S064 S065 S066 
S068 S069 S070 S071 S073 
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