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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 NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting coronary stent system
ApplicantABBOTT VASCULAR
PMA NumberP070015
Supplement NumberS054
Date Received11/26/2010
Decision Date05/24/2011
Product Code
NIQ
Docket Number 11M-0431
Notice Date 06/03/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00180310
NCT00180453
NCT00180479
NCT00307047
NCT00676520
NCT00783796
NCT01106534
NCT01120379
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 to expand the product matrix to include the 2. 25 mm xience v everolimus eluting coronary stem system. This device size will be marketed under the trade name xience nano everolimus eluting coronary stem system and will also be distributed as the promus everolimus eluting coronary stent system. The addition of the 2. 25 mm xience nano everolimus eluting coronary stent system will expand the originally approved indications to include treatment of coronary artery lesions with reference vessel diameters >2. 25 mm to <2. 50 mm. Therefore, the xience v everolimus eluting coronary stent system is now 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. 25 mm to 4. 25 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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