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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceXIENCE Xpedition, XIENCE Xpedition SV, XIENCE Xpedition LL Everolimus Eluting Coronary Stent Systems
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS099
Date Received03/05/2018
Decision Date08/23/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for labeling updates to the IFU to included clinical data from the EXPERT CTO trial.
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