- Device
- Endurant Stent Graft System; Endurant II Stent Graft System; Endurant IIS Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S096
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-11-19
- Decision code
- APPR
- Date received
- 2021-10-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the introduction of a proofload test for 100% inspection of the spindle to hypotube bond at Medtronic Galway.