PMA P160043S049

Device: Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW
Applicant: Medtronic Vascular
Product code: NIQ
Decision date: 2021-12-14
Generic name: Coronary drug-eluting stent
Approval order statement: Approval for changing the cleaning method for the extruder tooling used at the Santa Rosa site from a manual cleaning method to an automated cleaning method.

Current openFDA PMA Record#

Device: Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW
Applicant: Medtronic Vascular
PMA number: P160043
Supplement: S049
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2021-12-14
Decision code: APPR
Date received: 2021-06-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changing the cleaning method for the extruder tooling used at the Santa Rosa site from a manual cleaning method to an automated cleaning method.