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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.
 
DeviceXIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
P.O.BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP070015
Date Received06/01/2007
Decision Date07/02/2008
Withdrawal Date 04/26/2023
Product Code NIQ 
Docket Number 08M-0535
Notice Date 10/07/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, WHICH WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S124 S118 S119 S107 S108 S109  S053 S054 S055 S056 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 
S071 S072 S074 S075 S076 S077 S078 S079 S080 S081 S092 S131 
S132 S127 S128 S117 S111 S112 S104 S097 S098 S091 S021 S022 
S023 S031 S032 S001 S015 S016 S017 S018 S019 S020 S010 S011 
S012 S013 S014 S050 S051 S052 S035 S036 S037 S038 S039 S040 
S133 S135 S136 S082 S083 S114 S115 S116 S120 S125 S126 S106 
S099 S101 S102 S110 S093 S094 S096 S085 S086 S087 S088 S089 
S090 S121 S122 S123 S113 S002 S003 S004 S005 S024 S025 S026 
S041 S042 S043 S044 S045 S046 S047 S048 S033 S034 S027 S006 
S028 S029 S134 S137 S007 S008 S139 S141 S145 S147 S140 S138 
S142 S144 S146 S143 S148 
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