PMA P100021S131
- Device
- Endurant II/IIs Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S131
- Product code
- MIH
- Decision date
- 2025-10-23
- Classification
- Cardiovascular
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- additional an supplier of suprarenal stents for the Medtronic Endurant II/IIs Stent Graft System
Current openFDA PMA Record#
- Device
- Endurant II/IIs Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S131
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2025-10-23
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- additional an supplier of suprarenal stents for the Medtronic Endurant II/IIs Stent Graft System