FDA.reportPublic FDA data

PMA P100021S097

Device
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S097
Product code
MIH
Decision date
2021-12-17
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of corrective actions and associated process improvements for all spindle tubing assemblies based on root cause investigation for inadequate welding issue.

Current openFDA PMA Record#

Device
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S097
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2021-12-17
Decision code
OK30
Date received
2021-11-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of corrective actions and associated process improvements for all spindle tubing assemblies based on root cause investigation for inadequate welding issue.