- Device
- Valiant Navion Thoracic Stent Graft System, Valiant Thoracic Stent Graft with the Captivia Delivery System
- Applicant
- Medtronic Vascular
- PMA number
- P100040
- Supplement
- S047
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-05-21
- Decision code
- APPR
- Date received
- 2021-04-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.