PMA P020018S026
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S026
- Product code
- MIH
- Decision date
- 2008-07-09
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR USE OF THE NEW Z-TRAK INTRODUCTION SYSTEM WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, TO MODIFY THE ILIAC LEG COMPONENT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, AND TO CHANGE THE PACKAGING FOR THE MAIN BODY AND ILIAC LEG GRAFTS.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S026
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-07-09
- Decision code
- APPR
- Date received
- 2008-03-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USE OF THE NEW Z-TRAK INTRODUCTION SYSTEM WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, TO MODIFY THE ILIAC LEG COMPONENT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, AND TO CHANGE THE PACKAGING FOR THE MAIN BODY AND ILIAC LEG GRAFTS.