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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceRESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
MEDTRONIC Inc.
3576 unocal pl
santa rosa, CA 95403
PMA NumberP160043
Date Received09/27/2016
Decision Date04/28/2017
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 17M-2767
Notice Date 05/02/2017
Advisory Committee Cardiovascular
Clinical Trials NCT02412501
NCT02419521
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 less than or equal to 35 mm in native coronary arteries with reference vessel diameters of 2.25 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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