PMA P210006S009

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S009
Product code: QSK
Decision date: 2024-08-01
Classification: Cardiovascular
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P210006.

Current openFDA PMA Record

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S009
Product code: QSK
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Decision date: 2024-08-01
Decision code: APPR
Date received: 2024-07-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P210006.