Resolute Onyx Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S034 · decided 2020-09-22
Approval details
- PMA number
- P160043
- Supplement
- S034
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2020-03-27
- Decision date
- 2020-09-22
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- 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 On
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