PMA P020018S002
- Device
- ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S002
- Product code
- MIH
- Decision date
- 2004-02-12
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL TO INCREASE THE DIAMETER OF THE SUPRARENAL ATTACHMENT BARB (FROM .0093 INCHES TO .011 INCHES) OF THE ZENITH AAA ENDOVASCULAR GRAFT.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S002
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2004-02-12
- Decision code
- APPR
- Date received
- 2003-10-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO INCREASE THE DIAMETER OF THE SUPRARENAL ATTACHMENT BARB (FROM .0093 INCHES TO .011 INCHES) OF THE ZENITH AAA ENDOVASCULAR GRAFT.