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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
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
MEDTRONIC VASCULAR
3576 unocal place
santa rosa, CA 95403
PMA NumberP160043
Supplement NumberS001
Date Received05/23/2017
Decision Date11/16/2017
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 17M-6650
Notice Date 11/21/2017
Advisory Committee Cardiovascular
Clinical Trials NCT02412501
NCT02419521
NCT03063749
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the Resolute Onyx Zotarolimus-Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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