PMA P210006S001
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- Product code
- QSK
- Decision date
- 2022-08-08
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S001
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2022-08-08
- Decision code
- APPR
- Date received
- 2022-05-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.