PMA
P110032: AORFIX FLEXIBLE STENT GRAFT SYSTEM
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Lombard Medical Limited
Key facts
| PMA number | P110032 |
|---|---|
| Trade name | AORFIX FLEXIBLE STENT GRAFT SYSTEM |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Lombard Medical Limited |
| Product code | MIH |
| Approval date | Feb 14, 2013 |
| Docket number | 13M-0282 |
| Notice date | Mar 13, 2013 |
At a glance
- 10–99 Supplements
- Sep 20, 2017 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: