PMA
P160004: GORE TIGRIS VASCULAR STENT
FDA PMA · STENT, SUPERFICIAL FEMORAL ARTERY · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P160004 |
|---|---|
| Trade name | GORE TIGRIS VASCULAR STENT |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | NIP |
| Approval date | Jul 27, 2016 |
| Docket number | 16M-2332 |
| Notice date | Aug 5, 2016 |
| Establishment registration | 2017233 |
| FEI number | 2017233 |
At a glance
- 10–99 Supplements
- Jan 23, 2020 Latest supplement decision
- Yes Withdrawn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: