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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 S040 S042 
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