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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameXIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP110019
Supplement NumberS066
Date Received03/21/2014
Decision Date10/03/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 14M-1596
Notice Date 10/29/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01435031
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the expansion of the indications for use of the xience v and xience nano everolimus eluting coronary stent system xience prime and xience prime ll everolimus eluting coronary stent system, xience xpedition, xience xpedition sv and xience xpedition ll everolimus eluting coronary stent system, and xience alpine everolimus eluting coronary stent system to include de novo total coronary occlusions. These devices are indicated for the following: xience v and xience nano everolimus eluting coronary stent system the xience v and xience nano everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length <=28mm) with reference vessel diameters of 2. 25mm to 4. 25mm. Additionally, the xience v stent system is indicated for treating de novo chronic total coronary occlusions. Xience prime and xience prime ll everolimus eluting coronary stent system. The xience prime and xience prime ll everolimus eluting coronary stent system is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length <= 32mm) with reference vessel diameters of >=2. 25mm to >=4. 25mm. For additional info please refer to approval order.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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