PMA P180001S006
- Device
- Zenith Dissection Endovascular System
- Applicant
- William Cook Europe Aps
- PMA number
- P180001
- Supplement
- S006
- Product code
- MIH
- Decision date
- 2022-09-01
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for a design change to the introduction system green release knob of the Cook Zenith Dissection Endovascular System.
Current openFDA PMA Record#
- Device
- Zenith Dissection Endovascular System
- Applicant
- William Cook Europe Aps
- PMA number
- P180001
- Supplement
- S006
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-09-01
- Decision code
- APPR
- Date received
- 2022-06-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the introduction system green release knob of the Cook Zenith Dissection Endovascular System.