PMA
P200026: Abre Venous Self-expanding Stent System
FDA PMA · Stent, iliac vein · Medtronic Vascular, Inc.
Key facts
| PMA number | P200026 |
|---|---|
| Trade name | Abre Venous Self-expanding Stent System |
| Generic name | Stent, iliac vein |
| Applicant | Medtronic Vascular, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | QAN |
| Approval date | Oct 21, 2020 |
| Docket number | 20M-2118 |
| Notice date | Oct 23, 2020 |
| Establishment registration | 1220452 |
| FEI number | 1220452 |
At a glance
- 10–99 Supplements
- Apr 27, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: