PMA P210006
- Device
- Thoraflex™ Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S003
- Product code
- QSK
- Decision date
- 2026-06-24
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- updated manufacturing inspections for the endovascular sub-assembly parts of the Thoraflex Hybrid
Current openFDA PMA Record#
- Device
- Thoraflex™ Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S019
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2026-06-24
- Decision code
- OK30
- Date received
- 2026-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updated manufacturing inspections for the endovascular sub-assembly parts of the Thoraflex Hybrid