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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, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Supplement NumberS020
Date Received06/22/2012
Decision Date09/19/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to change the coating integrity specification for the 28 mm length stents to align with that of the 33 mm and 38 mm stents for the xience family of products.
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