PMA
P130029: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA PMA · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment · Bard Peripheral Vascular, Inc.
Key facts
| PMA number | P130029 |
|---|---|
| Trade name | FLUENCY PLUS ENDOVASCULAR STENT GRAFT |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | Bard Peripheral Vascular, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | PFV |
| Approval date | Jun 17, 2014 |
| Docket number | 14M-0875 |
| Notice date | Jul 15, 2014 |
| Establishment registration | 2020394 |
| FEI number | 1220748 |
At a glance
- 10–99 Supplements
- Jun 22, 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- No Withdrawn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: