PMA
P170042: Covera™ Vascular Covered Stent
FDA PMA · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment · C.R. Bard, Inc.
Key facts
| PMA number | P170042 |
|---|---|
| Trade name | Covera™ Vascular Covered Stent |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | C.R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | PFV |
| Approval date | Jul 30, 2018 |
| Docket number | 18M-2983 |
| Notice date | Aug 1, 2018 |
| Establishment registration | 1018233 |
| FEI number | 1018233 |
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- No Withdrawn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: