PMA P210006S010

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S010
Product code: QSK
Decision date: 2025-03-28
Classification: Cardiovascular
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Approval order statement: approval for a change in the supplier of the bovine gelatin used to impregnate the grafts, implementation of a new sterilization suite, delivery system material changes, shelf-life updates, and other manufacturing changes.

Current openFDA PMA Record

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S010
Product code: QSK
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Decision date: 2025-03-28
Decision code: APPR
Date received: 2024-07-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change in the supplier of the bovine gelatin used to impregnate the grafts, implementation of a new sterilization suite, delivery system material changes, shelf-life updates, and other manufacturing changes.