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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 AND XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Supplement NumberS009
Date Received01/24/2012
Decision Date09/14/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product Yes
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.
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