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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 Skypoint Everolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP110019
Date Received04/20/2011
Decision Date11/01/2011
Product Code NIQ 
Docket Number 11M-0796
Notice Date 11/04/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00916370
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE XIENCE PRIME AND XIENCE PRIME LL 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 <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 
S026 S027 S028 S030 S031 S033 S034 S035 S037 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 S078 S079 
S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 S092 
S093 S094 S095 S096 S097 S098 S099 S100 S101 S102 S103 S104 
S105 S107 S108 S109 S110 S111 S112 S113 S114 S115 S116 S117 
S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 S129 
S130 S131 S132 S133 
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