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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 Skypoint Everolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS118
Date Received07/01/2021
Decision Date03/11/2022
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for approval for two changes to the existing design: 1) additional XIENCE Skypoint sizes, specifically diameters 4.50 mm and 5.0 mm; and 2) a dual neck catheter chassis with dimensional changes to the outer membrane diameters.
Post-Approval StudyShow Report Schedule and Study Progress
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