PMA P140016S005

Device: Zenith Alpha Thoracic Endovascular Graft
Applicant: Cook Medical Incorporated
PMA number: P140016
Supplement: S005
Product code: MIH
Decision date: 2022-04-14
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for an additional seal on one side of the Zenith Alpha Thoracic Endovascular Graft primary packaging and new specifications for the position of an already applied seal on the opposite side.

Current openFDA PMA Record#

Device: Zenith Alpha Thoracic Endovascular Graft
Applicant: Cook Medical Incorporated
PMA number: P140016
Supplement: S005
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-04-14
Decision code: APPR
Date received: 2022-03-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional seal on one side of the Zenith Alpha Thoracic Endovascular Graft primary packaging and new specifications for the position of an already applied seal on the opposite side.