Premarket Approval (PMA)

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.

• Device: Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
• Generic Name: Coronary drug-eluting stent
• Applicant: MEDTRONIC VASCULAR; 3576 UNOCAL PLACE; SANTA ROSA, CA 95403
• PMA Number: P160043
• Supplement Number: S058
• Date Received: 03/09/2022
• Decision Date: 09/15/2022
• Product Code: NIQ
• Docket Number: 23M-0578
• Notice Date: 02/24/2023
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT03584464
• Supplement Type: Panel 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 and Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems. The device 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 and Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems are indicated for treating de novo chronic total occlusions and non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2