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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.
 
DeviceSENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
Johnson & Johnson Surgical Vision, Inc.
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP980040
Date Received10/01/1998
Decision Date02/03/2000
Product Code 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
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 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 S081 S082 S083 
S084 S085 S086 S087 S088 S089 S090 S091 S092 
S093 S094 S095 S096 S097 S098 S099 S100 S101 
S102 S103 S104 S105 S106 S107 S108 S109 S110 
S111 S112 S113 S115 S117 S118 S119 S120 S121 
S122 S123 S124 S126 S127 S128 S129 S130 S131 
S132 S133 S134 S135 S136 S137 S138 S141 
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