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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 PRIME EVEROLIMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYS
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS059
Date Received12/12/2013
Decision Date01/08/2014
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
MODIFICATIONS TO THE SAMPLING PLAN FOR XIENCE FINAL RELEASE TESTING.
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