PMA
P160021: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA PMA · Iliac covered stent, arterial · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P160021 |
|---|---|
| Trade name | GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS |
| Generic name | Iliac covered stent, arterial |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | PRL |
| Approval date | Jan 27, 2017 |
| Docket number | 16M-0560 |
| Notice date | Feb 27, 2017 |
| Establishment registration | 2017233 |
| FEI number | 2017233 |
At a glance
- 10–99 Supplements
- Oct 8, 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- No Withdrawn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: