PMA P070016S006
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S006
- Product code
- MIH
- Decision date
- 2011-12-06
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S006
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-12-06
- Decision code
- APPR
- Date received
- 2011-07-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.