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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
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S056 S057 S058 S017 S018 S019 S064 S065 S039 S063 S046 
S028 S029 S008 S001 S002 S006 S013 S014 S015 S016 S005 S024 
S003 S007 S068 S069 S075 S076 S078 S079 S037 S041 S050 S043 
S044 S045 S042 S059 S060 S040 S048 S049 S051 S052 S053 S054 
S055 S047 S061 S062 S038 S020 S021 S022 S023 S030 S032 S025 
S026 S009 S010 S011 S012 S033 S035 S027 S034 S066 S067 S080 
S081 S077 S072 S073 S074 S070 S071 S082 S096 S097 S098 S099 
S100 S089 S090 S091 S085 S086 S105 S106 S111 S112 S113 S121 
S122 S093 S115 S117 S118 S161 S162 S163 S150 S134 S146 S157 
S158 S128 S129 S130 S174 S175 S178 S083 S084 S092 S087 S088 
S104 S107 S108 S119 S120 S123 S124 S126 S101 S102 S109 S110 
S094 S095 S103 S142 S147 S153 S154 S155 S156 S165 S135 S136 
S131 S132 S133 S127 S137 S138 S139 S140 S141 S148 S149 S144 
S145 S159 S160 S151 S152 S172 S168 S169 S170 S171 S176 S177 
S179 S181 S173 S182 S183 
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