PMA P020018S009

Device: ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S009
Product code: MIH
Decision date: 2006-06-01
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENT LABELING TO CLARIFY THE LENGTH LIMITATIONS FOR USE OF THE 58 MM LENGTH MAIN BODY EXTENSION WHEN USED IN CONJUNCTION WITH THE SHORTEST ZENITH MAIN BODY COMPONENTS.

Current openFDA PMA Record#

Device: ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S009
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2006-06-01
Decision code: APPR
Date received: 2006-05-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT ANCILLARY COMPONENT LABELING TO CLARIFY THE LENGTH LIMITATIONS FOR USE OF THE 58 MM LENGTH MAIN BODY EXTENSION WHEN USED IN CONJUNCTION WITH THE SHORTEST ZENITH MAIN BODY COMPONENTS.