FDA.reportPublic FDA data

PMA P100021S095

Device
Endurant II Stent Graft System, Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S095
Product code
MIH
Decision date
2021-09-10
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementing the addition of a verification fixture to ensure use of the correct stent stop assembly size in the manufacturing of the Endurant II and Endurant IIs Stent Graft System.

Current openFDA PMA Record#

Device
Endurant II Stent Graft System, Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S095
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2021-09-10
Decision code
OK30
Date received
2021-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementing the addition of a verification fixture to ensure use of the correct stent stop assembly size in the manufacturing of the Endurant II and Endurant IIs Stent Graft System.