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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.
 
DeviceResolute Onyx Zotarolimus-Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
PMA NumberP160043
Supplement NumberS032
Date Received03/02/2020
Decision Date05/28/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for revisions to the labeling to increase the maximum stent inner diameter (MSID) by 0.25 mm for all sizes of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System.
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