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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 Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS122
Date Received06/23/2022
Decision Date09/14/2022
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to extend the shelf life for the XIENCE Sierra and XIENCE Skypoint Everolimus-Eluting Coronary Stent System from 24 to 36 months and minor labeling changes for the XIENCE Sierra, Skypoint, and Alpine Everolimus-Eluting Coronary Stent System.
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