AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM
FDA premarket approval P110032/S011 · decided 2015-09-01
Approval details
- PMA number
- P110032
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AORFIX AN AAA FLEXIBLE STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Lombard Medical Limited
- Date received
- 2015-06-12
- Decision date
- 2015-09-01
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Didcot
- Statement
- APPROVAL FOR A CHANGE TO THE CENTER TUBE OF THE DELIVERY SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.