PMA P210006S016
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S016
- Product code
- QSK
- Decision date
- 2026-01-29
- Classification
- Cardiovascular
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- an update to the lFU to include additional language regarding early imaging surveillance for patients at risk for intraluminal thrombosis
Current openFDA PMA Record
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S016
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2026-01-29
- Decision code
- APPR
- Date received
- 2025-12-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- an update to the lFU to include additional language regarding early imaging surveillance for patients at risk for intraluminal thrombosis