PMA P210006S017
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S017
- Product code
- QSK
- Decision date
- 2026-04-20
- Classification
- Cardiovascular
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- Approval for extension of shelf-life to 3-years
Current openFDA PMA Record
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S017
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2026-04-20
- Decision code
- APPR
- Date received
- 2026-01-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extension of shelf-life to 3-years