PMA P020018S037
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S037
- Product code
- MIH
- Decision date
- 2011-06-07
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL TO ADD THE ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG TO THE EXISTING ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG AND IS INDICATED FOR USE WITH THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, INCLUDING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT, OR ZENITH BRANCH ILIAC ENDOVASCULAR GRAFT, DURING EITHER A PRIMARY OR SECONDARY PROCEDURE IN PATIENTS WHO HAVE ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS. THE GRAFT IS USED IN COMBINATION WITH THESE PRODUCTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S037
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-06-07
- Decision code
- APPR
- Date received
- 2010-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO ADD THE ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG TO THE EXISTING ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG AND IS INDICATED FOR USE WITH THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, INCLUDING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT, OR ZENITH BRANCH ILIAC ENDOVASCULAR GRAFT, DURING EITHER A PRIMARY OR SECONDARY PROCEDURE IN PATIENTS WHO HAVE ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS. THE GRAFT IS USED IN COMBINATION WITH THESE PRODUCTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS.