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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 XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP110019
Supplement NumberS047
Date Received05/22/2013
Decision Date04/23/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR AN UPDATE TO THE LABELING FOR THE XIENCE XPEDITION RX (RAPID EXCHANGE) AND OTW (OVER-THE-WIRE) TO CHANGE THE GUIDING CATHETER COMPATIBILITY FOR THE 4.0MM BALLOON DIAMETER SIZES FROM A MINIMUM OF A 6 FRENCH (F) GUIDE CATHETER TO 5F FOR THE 4.0 X 8-33MM SIZES.
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