PMA P110032S005
- Device
- AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S005
- Product code
- MIH
- Decision date
- 2013-07-18
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- MODIFIED STERILIZATION CYCLE.
Current openFDA PMA Record#
- Device
- AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S005
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-07-18
- Decision code
- OK30
- Date received
- 2013-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFIED STERILIZATION CYCLE.