PMA P100021S082
- Device
- Endurant II/IIs Stent Graft System
- Applicant
- Medtronic Vascular
- Product code
- MIH
- Decision date
- 2020-10-21
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for the addition of a 146mm limb length configuration to the Endurant II/IIs product size matrix.
Current openFDA PMA Record#
- Device
- Endurant II/IIs Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S082
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-21
- Decision code
- APPR
- Date received
- 2020-07-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a 146mm limb length configuration to the Endurant II/IIs product size matrix.