- Device
- Endurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S090
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-04-15
- Decision code
- OK30
- Date received
- 2021-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changing the current pouch sealer with an upgraded pouch sealer.