PMA P160043S034
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- Product code
- NIQ
- Decision date
- 2020-09-22
- Generic name
- Coronary drug-eluting stent
- 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.
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S034
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-09-22
- Decision code
- APPR
- Date received
- 2020-03-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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