PMA
P100021: MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Medtronic Vascular
Key facts
| PMA number | P100021 |
|---|---|
| Trade name | MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | MIH |
| Approval date | Dec 16, 2010 |
| Docket number | 11M-0040 |
| Notice date | Jan 25, 2011 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 100–999 Supplements
- May 12, 2026 Latest supplement decision
- No Withdrawn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: