FDA.reportPublic FDA data

PMA P160043S052

Device
Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
Applicant
Medtronic Vascular
PMA number
P160043
Supplement
S052
Product code
NIQ
Decision date
2021-08-09
Generic name
Coronary drug-eluting stent
Approval order statement
Introduction of new stent crimp equipment on the Resolute Onyx manufacturing line to perform the final crimp of the stent onto the balloon of the delivery system.

Current openFDA PMA Record#

Device
Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
Applicant
Medtronic Vascular
PMA number
P160043
Supplement
S052
Product code
NIQ
Generic name
Coronary drug-eluting stent
Decision date
2021-08-09
Decision code
OK30
Date received
2021-07-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of new stent crimp equipment on the Resolute Onyx manufacturing line to perform the final crimp of the stent onto the balloon of the delivery system.