PMA P110032S011
- Device
- AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S011
- Product code
- MIH
- Decision date
- 2015-09-01
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A CHANGE TO THE CENTER TUBE OF THE DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S011
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-09-01
- Decision code
- APPR
- Date received
- 2015-06-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE CENTER TUBE OF THE DELIVERY SYSTEM.