PMA
P180037: Venovo Venous Stent System
FDA PMA · Stent, iliac vein · Bard Peripheral Vascular, Inc.
Key facts
| PMA number | P180037 |
|---|---|
| Trade name | Venovo Venous Stent System |
| Generic name | Stent, iliac vein |
| Applicant | Bard Peripheral Vascular, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | QAN |
| Approval date | Mar 13, 2019 |
| Docket number | 19M-1214 |
| Notice date | Mar 14, 2019 |
| Establishment registration | 2020394 |
| FEI number | 1220748 |
At a glance
- 10–99 Supplements
- Jun 10, 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- No Withdrawn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: