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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 XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM- SV, AND LL
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP110019
Supplement NumberS068
Date Received04/30/2014
Decision Date07/03/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to change the outer layer thickness specification for the inner member catheter component for the xience xpedition, xience xpedition sv, and xience xpedition ll everolimus eluting coronary stent over the wire (otw) system.
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