PMA P020018S034

Device: ZENITH FLEX ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S034
Product code: MIH
Decision date: 2010-03-31
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR THE ADDITION OF MANUFACTURING INSTRUCTIONS TO ASSURE THAT THE PROXIMAL TRIGGER WIRE IS NOT INADVERTENTLY ATTACHED TO BOTH TRIGGER KNOBS OF THE DELIVERY SYSTEM.

Current openFDA PMA Record#

Device: ZENITH FLEX ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S034
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2010-03-31
Decision code: APPR
Date received: 2010-03-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF MANUFACTURING INSTRUCTIONS TO ASSURE THAT THE PROXIMAL TRIGGER WIRE IS NOT INADVERTENTLY ATTACHED TO BOTH TRIGGER KNOBS OF THE DELIVERY SYSTEM.