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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 SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS111
Date Received02/13/2020
Decision Date03/12/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Extend the retest period from 96 months to 108 months of the repackaged drug API (variants 1, 2, and 3) for container closure Configuration I.
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