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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 PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Date Received04/20/2011
Decision Date11/01/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 11M-0796
Notice Date 11/04/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00916370
NCT01205776
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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