PMA P020018S025

Device: ZENITH ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S025
Product code: MIH
Decision date: 2008-06-19
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR A CHANGE FROM AN OXYFUME BLEND ETHYLENE OXIDE (ETO) STERILANT TO THE USE OF 100% ETO STERILANT IN THE CURRENT STERILIZATION CYCLE FOR THE ZENITH FAMILY OF DEVICES AND THE ADDITION OF A SUPPLIER OF THE STERILANT.

Current openFDA PMA Record#

Device: ZENITH ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S025
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2008-06-19
Decision code: APPR
Date received: 2008-01-22
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE FROM AN OXYFUME BLEND ETHYLENE OXIDE (ETO) STERILANT TO THE USE OF 100% ETO STERILANT IN THE CURRENT STERILIZATION CYCLE FOR THE ZENITH FAMILY OF DEVICES AND THE ADDITION OF A SUPPLIER OF THE STERILANT.