PMA P020018S046
- Device
- ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S046
- Product code
- MIH
- Decision date
- 2012-10-09
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE H & L-B ONE-SHOT INTRODUCTION SYSTEM.
Current openFDA PMA Record#
- Device
- ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S046
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-10-09
- Decision code
- APPR
- Date received
- 2012-07-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE H & L-B ONE-SHOT INTRODUCTION SYSTEM.