PMA P070016S003
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S003
- Product code
- MIH
- Decision date
- 2009-01-27
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE ADDITION OF A COMPONENT MANUFACTURER.
Current openFDA PMA Record#
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S003
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-01-27
- Decision code
- APPR
- Date received
- 2008-09-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A COMPONENT MANUFACTURER.