PMA
P230023: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
FDA PMA · Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P230023 |
|---|---|
| Trade name | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis |
| Generic name | Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | QZK |
| Approval date | Jan 12, 2024 |
| Docket number | 24M-0525 |
| Notice date | Feb 21, 2024 |
| Establishment registration | 2017233 |
| FEI number | 2017233 |
At a glance
- 10–99 Supplements
- Jul 1, 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- No Withdrawn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: