PMA P020018S022

Device: ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S022
Product code: MIH
Decision date: 2007-09-25
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR A CHANGE TO THE 304V STAINLESS STEEL WIRE SUPPLIER?S PROCESS TO INCLUDE 100% EDDY CURRENT TESTING.

Current openFDA PMA Record#

Device: ZENITH AAA ENDOVASCULAR GRAFT WITH H&L ONE SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S022
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2007-09-25
Decision code: APPR
Date received: 2006-11-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE 304V STAINLESS STEEL WIRE SUPPLIER?S PROCESS TO INCLUDE 100% EDDY CURRENT TESTING.