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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameXIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting coronary stent system
ApplicantABBOTT VASCULAR INC.
PMA NumberP070015
Date Received06/01/2007
Decision Date07/02/2008
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 08M-0535
Notice Date 10/07/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S050 S051 S052 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 S082 S083 S085 S086 S087 
S088 S089 S090 S091 S092 S093 S094 S096 S097 
S098 S099 S101 S102 S104 S106 S108 S109 S110 
S111 S112 S113 S114 S115 S116 S118 S120 S121 
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