PMA P210006S011

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S011
Product code: QSK
Decision date: 2025-01-27
Classification: Cardiovascular
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Approval order statement: a change to in-process formaldehyde residual testing, a change to tensile test action and warning limits, and a change to the sequence and method of sewing the components of the Thoraflex Hybrid device

Current openFDA PMA Record

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S011
Product code: QSK
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Decision date: 2025-01-27
Decision code: OK30
Date received: 2024-12-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to in-process formaldehyde residual testing, a change to tensile test action and warning limits, and a change to the sequence and method of sewing the components of the Thoraflex Hybrid device