FDA.reportPublic FDA data

PMA P100021S102

Device
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S102
Product code
MIH
Decision date
2022-04-07
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for implementation of changes to the taper tip manufacturing and inspection processes at the supplier and updates to the inspection plan for the taper tip assembly at Medtronics receiving inspection.

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
S102
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2022-04-07
Decision code
APPR
Date received
2022-03-11
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for implementation of changes to the taper tip manufacturing and inspection processes at the supplier and updates to the inspection plan for the taper tip assembly at Medtronics receiving inspection.