PMA P070016S005
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S005
- Product code
- MIH
- Decision date
- 2012-11-05
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR IN-HOUSE MANUFACTURE OF STENT GRAFT MATERIAL.
Current openFDA PMA Record#
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S005
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-11-05
- Decision code
- APPR
- Date received
- 2011-07-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR IN-HOUSE MANUFACTURE OF STENT GRAFT MATERIAL.