PMA supplement
P110032 S010: AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
FDA PMA supplement · Real-Time Process · Lombard Medical Limited
Key facts
| Original PMA | P110032 |
|---|---|
| Supplement number | S010 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Lombard Medical Limited |
| Product code | MIH |
| Received date | Nov 7, 2014 |
| Decision date | Feb 3, 2015 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: