Premarket Approval (PMA)

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.

• Device: RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
• Generic Name: Coronary drug-eluting stent
• Applicant: MEDTRONIC VASCULAR; 3576 UNOCAL PLACE; SANTA ROSA, CA 95403
• PMA Number: P160043
• Date Received: 09/27/2016
• Decision Date: 04/28/2017
• Product Code: NIQ
• Docket Number: 17M-2767
• Notice Date: 05/02/2017
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT02412501
• 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 Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 ; S024 S025 S026 S027 S028 S029 S031 S032 S033 S034 S035 S037 ; S038 S039 S040 S042 S043 S044 S045 S046 S047 S048 S049 S050 ; S051 S052 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 ; S064 S065 S066 S067 S068 S069 S070 S071 S073 S074 S076 S077 ; S078 S079 S080 S081