AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
FDA premarket approval P110032/S002 · decided 2013-06-17
Approval details
- PMA number
- P110032
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Lombard Medical Limited
- Date received
- 2013-04-09
- Decision date
- 2013-06-17
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Didcot
- Statement
- APPROVAL FOR SEVERAL MODIFICATIONS TO THE OUTER SHEATH OF THE DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY SYSTEM AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES; 2) AORTIC NE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.