PMA P020018S023

Device: ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S023
Product code: MIH
Decision date: 2008-05-09
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT WILLIAM COOK EUROPE, BJAEVERSKOV, DENMARK.

Current openFDA PMA Record#

Device: ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S023
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2008-05-09
Decision code: APPR
Date received: 2007-02-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT WILLIAM COOK EUROPE, BJAEVERSKOV, DENMARK.