PMA P020018S005
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S005
- Product code
- MIH
- Decision date
- 2005-06-09
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ANCILLARY COMPONENTS FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT.
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
- S005
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2005-06-09
- Decision code
- APPR
- Date received
- 2005-01-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ANCILLARY COMPONENTS FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT.