PMA P210006S005

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S005
Product code: QSK
Decision date: 2023-11-20
Classification: Cardiovascular
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Approval order statement: Approval for a change in equipment used to manufacture the delivery system and a change in cleaning method for the stainless-steel shaft component of the delivery system.

Current openFDA PMA Record#

Device: Thoraflex Hybrid
Applicant: Vascutek, Ltd.
PMA number: P210006
Supplement: S005
Product code: QSK
Generic name: Hybrid stent graft, thoracic aortic lesion treatment
Decision date: 2023-11-20
Decision code: APPR
Date received: 2023-07-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in equipment used to manufacture the delivery system and a change in cleaning method for the stainless-steel shaft component of the delivery system.