PMA
P130006: GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA PMA · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P130006 |
|---|---|
| Trade name | GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | PFV |
| Approval date | Dec 5, 2013 |
| Docket number | 13M-1605 |
| Notice date | Dec 24, 2013 |
| Establishment registration | 2017233 |
| FEI number | 2017233 |
At a glance
- 100–999 Supplements
- May 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: