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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.
 
DeviceXIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP110019
Supplement NumberS067
Date Received04/14/2014
Decision Date05/13/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of receiving inspection and testing activities of raw materials and supply items at the clonmel, ireland facility and contract laboratories.
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