PMA P180001S002
- Device
- Zenith Dissection Endovascular System
- Applicant
- William Cook Europe Aps
- PMA number
- P180001
- Supplement
- S002
- Product code
- MIH
- Decision date
- 2021-03-31
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval of the labeling updates for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Zenith Dissection Endovascular System
- Applicant
- William Cook Europe Aps
- PMA number
- P180001
- Supplement
- S002
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-03-31
- Decision code
- APPR
- Date received
- 2020-10-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval of the labeling updates for the post-approval study (PAS) protocol.