PMA P020018S027

Device: ZENITH FLEX AAA ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S027
Product code: MIH
Decision date: 2008-06-04
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR THE ADDITION OF A QUALITY CONTROL STEP VERIFYING THE ORIENTATION OF THE CONVERTER WHILE IT IS BEING LOADED INTO THE DELIVERY CATHETER.

Current openFDA PMA Record#

Device: ZENITH FLEX AAA ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S027
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2008-06-04
Decision code: APPR
Date received: 2008-05-09
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A QUALITY CONTROL STEP VERIFYING THE ORIENTATION OF THE CONVERTER WHILE IT IS BEING LOADED INTO THE DELIVERY CATHETER.