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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 ELUTING CORONARY STENT SYSTEM, XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM,
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS060
Date Received12/23/2013
Decision Date05/29/2014
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE RESIN COMPOSITION OF POLYPROPYLENE SUPPLY ITEMS USED IN XIENCE PRIMER AND DRUG FORMULATION MANUFACTURING.
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