PMA P070016S004
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S004
- Product code
- MIH
- Decision date
- 2009-05-21
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE PROXIMAL TRIGGER-WIRE ATTACHMENT AND TAPERED SECTION OF THE PUSHER.
Current openFDA PMA Record#
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S004
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-05-21
- Decision code
- APPR
- Date received
- 2009-04-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE PROXIMAL TRIGGER-WIRE ATTACHMENT AND TAPERED SECTION OF THE PUSHER.