PMA P210006S018
- Device
- Thoraflex™ Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S018
- Product code
- QSK
- Decision date
- 2026-09-08
- Classification
- Cardiovascular
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- approval for new branch configurations of the Thoraflex Hybrid device
Current openFDA PMA Record#
- Device
- Thoraflex™ Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S018
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2026-09-08
- Decision code
- APPR
- Date received
- 2026-03-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for new branch configurations of the Thoraflex Hybrid device