PMA P070016S010
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S010
- Product code
- MIH
- Decision date
- 2015-08-03
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- CHANGE TO THE COATING PROCESS PARAMETERS FOR THE RELEASE-WIRES.
Current openFDA PMA Record#
- Device
- ZENITH TX2 TAA ENDOVASCULAR GRAFT
- Applicant
- William Cook Europe Aps
- PMA number
- P070016
- Supplement
- S010
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-08-03
- Decision code
- OK30
- Date received
- 2015-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE COATING PROCESS PARAMETERS FOR THE RELEASE-WIRES.