PMA P210006S002

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S002
Product code: QSK
Decision date: 2022-06-16
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Approval order statement: Implementation of a new in-process inspection step, new equipment for aeration and new colorant resin for a component of the delivery system of the Thoraflex Hybrid device.

Current openFDA PMA Record#

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S002
Product code: QSK
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Decision date: 2022-06-16
Decision code: OK30
Date received: 2022-05-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new in-process inspection step, new equipment for aeration and new colorant resin for a component of the delivery system of the Thoraflex Hybrid device.