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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 NumberS034
Date Received03/27/2020
Decision Date09/22/2020
Product Code NIQ 
Docket Number 20M-2022
Notice Date 10/02/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT03344653
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for expanding the labeling to include patients at high risk for bleeding. This device is indicated as follows: The Resolute Onyx Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus or high bleeding risk, with symptomatic ischemic heart disease due to de novo lesions of length <= 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 mm. In addition, the Resolute Onyx Zotarolimus-Eluting Coronary Stent System is indicated for treating de novo chronic total occlusions.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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