PMA P160043S062

Device: Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting
Applicant: Medtronic Vascular
PMA number: P160043
Supplement: S062
Product code: NIQ
Decision date: 2022-11-01
Generic name: Coronary drug-eluting stent
Approval order statement: Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.

Current openFDA PMA Record#

Device: Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting
Applicant: Medtronic Vascular
PMA number: P160043
Supplement: S062
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2022-11-01
Decision code: OK30
Date received: 2022-10-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.