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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 & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Supplement NumberS008
Date Received12/22/2011
Decision Date01/20/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of an alternate manufacturing site for drug sublotting and the implementation of a new piece of equipment for pouch sealing.
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