PMA P160043S001
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S001
- Product code
- NIQ
- Decision date
- 2017-11-16
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- 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 <= 35 mm in native coronary arteries with reference vessel diameters of 2.0 mm to 5.0 mm.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160043S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S001
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2017-11-16
- Decision code
- APPR
- Date received
- 2017-05-23
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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