FDA.reportPublic FDA data

PMA P100021S084

Device
Endurant, Endurant II, and Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S084
Product code
MIH
Decision date
2020-10-15
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Restart commercial sterilization activities at an existing alternate sterilization site, to add an alternate packaging supplier, and to update the E-Beam sterilization process dose range.

Current openFDA PMA Record#

Device
Endurant, Endurant II, and Endurant IIs Stent Graft System
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S084
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-10-15
Decision code
OK30
Date received
2020-09-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Restart commercial sterilization activities at an existing alternate sterilization site, to add an alternate packaging supplier, and to update the E-Beam sterilization process dose range.