PMA P070016S001
- Device
- ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S001
- Product code
- MIH
- Decision date
- 2008-11-26
- 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 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S001
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-11-26
- Decision code
- APPR
- Date received
- 2008-06-02
- 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.