PMA
P040037: VIABAHN ENDOPROSTHESIS
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P040037 |
|---|---|
| Trade name | VIABAHN ENDOPROSTHESIS |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | NIP |
| Approval date | Jun 14, 2005 |
| Docket number | 05M-0379 |
| Notice date | Sep 23, 2005 |
| 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- No Withdrawn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: