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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.
 
DevicePROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP110010
Date Received03/28/2011
Decision Date11/22/2011
Product Code NIQ 
Docket Number 11M-0865
Notice Date 12/09/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00823212
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM INLENGTH.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S050 S051 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 S096 S097 S098 S099 
S100 S101 S102 S103 S104 S105 S106 S107 S108 S109 S111 S112 
S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 
S125 S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 S136 
S137 S138 S139 S140 S141 S142 S143 S144 S145 S146 S147 S148 
S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 S159 S160 
S161 S162 S163 S164 S165 S166 S167 S168 S169 S170 S171 S172 
S173 S174 S175 S176 S177 S178 S179 S180 S181 S182 S183 S184 
S185 S186 S187 S188 S189 S190 S191 S192 S193 S194 S195 S196 
S197 S198 S200 S201 S202 S203 S204 S205 S206 S207 S208 S209 
S210 S211 S212 
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