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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
PMA NumberP160043
Date Received09/27/2016
Decision Date04/28/2017
Product Code NIQ 
Docket Number 17M-2767
Notice Date 05/02/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT02412501
Expedited Review Granted? No
Combination ProductYes
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S003 S004 S001 S002 S012 S007 S023 S038 S026 S034 S035 
S039 S040 S057 S062 S061 S065 S066 S067 S068 S044 S045 S055 
S013 S016 S005 S006 S011 S008 S009 S010 S014 S015 S021 S017 
S018 S019 S020 S029 S037 S027 S028 S031 S032 S033 S024 S025 
S022 S042 S043 S058 S059 S060 S069 S070 S063 S064 S071 S056 
S046 S047 S048 S049 S050 S051 S052 S054 S076 S077 S078 S079 
S080 S073 S074 
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