- Device
- Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery System and Valiant Thoracic Sten
- Applicant
- Medtronic Vascular
- PMA number
- P100040
- Supplement
- S054
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-11-28
- Decision code
- OK30
- Date received
- 2022-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Internal facility transfer of component extrusion and secondary cutting manufacturing operations.