PMA
P060002: FLAIR ENDOVASCULAR STENT GRAFT
FDA PMA · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment · Bard Peripheral Vascular
Key facts
| PMA number | P060002 |
|---|---|
| Trade name | FLAIR ENDOVASCULAR STENT GRAFT |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | Bard Peripheral Vascular |
| Owner/operator | C. R. Bard, Inc. |
| Product code | PFV |
| Approval date | Jul 23, 2007 |
| Docket number | 07M-0298 |
| Notice date | Aug 1, 2007 |
| Establishment registration | 2020394 |
| FEI number | 2020394 |
At a glance
- 10–99 Supplements
- Oct 11, 2018 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- No Withdrawn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: