PMA P110032
- Device
- Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S013
- Product code
- MIH
- Decision date
- 2017-09-20
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval to the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device
- Applicant
- Lombard Medical Limited
- PMA number
- P110032
- Supplement
- S013
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-09-20
- Decision code
- APPR
- Date received
- 2017-07-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval to the post-approval study (PAS) protocol.