PMA P020018S052

Device: ZENITH AAA ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S052
Product code: MIH
Decision date: 2014-06-04
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR UPDATING YOUR INTERNAL QUALITY CONTROL FOR THE ZENITH AAAENDOVASCULAR GRAFT INTRODUCTION SYSTEM SUBASSEMBLIES BY ADDING AN ADDITIONAL INSPECTION STEP TO CHECK FOR SECURITY OF THE TAPERED TIP ON THE CANNULA.

Current openFDA PMA Record#

Device: ZENITH AAA ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S052
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2014-06-04
Decision code: APPR
Date received: 2014-05-06
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR UPDATING YOUR INTERNAL QUALITY CONTROL FOR THE ZENITH AAAENDOVASCULAR GRAFT INTRODUCTION SYSTEM SUBASSEMBLIES BY ADDING AN ADDITIONAL INSPECTION STEP TO CHECK FOR SECURITY OF THE TAPERED TIP ON THE CANNULA.