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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/LL and XIENCE/SV/LL and XIENCE Alpine and XIENCE Sierra Everolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS097
Date Received01/26/2018
Decision Date02/21/2018
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  
Change the time point when pyrogen testing for ethylene oxide (EO) sterilized products is conducted for products manufactured at its facility located in Clonmel, Ireland.
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