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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 |
Supplement Number | S034 |
Date Received | 03/27/2020 |
Decision Date | 09/22/2020 |
Product Code |
NIQ |
Docket Number | 20M-2022 |
Notice Date | 10/02/2020 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT03344653
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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 expanding the labeling to include patients at high risk for bleeding. This device is indicated as follows: The Resolute Onyx Zotarolimus-Eluting Coronary Stent System 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 Zotarolimus-Eluting Coronary Stent System is indicated for treating de novo chronic total occlusions. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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