|Trade Name||XIENCE PRIME AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM|
|Classification Name||coronary drug-eluting stent|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling for post approval study|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to update the product labeling contained in the instructions for use (ifu) and patient guide for the xience v and xience nano everolimus eluting coronary stent system and for the xience prime and xience prime ll everolimus eluting coronary stent system. These updates specifically included longer term follow-up data to all applicable clinical trials for the devices.