PMA
P200030: Gore Excluder Conformable AAA Endoprosthesis (CEXC)
FDA PMA · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · W. L. Gore and Associates, Inc.
Key facts
| PMA number | P200030 |
|---|---|
| Trade name | Gore Excluder Conformable AAA Endoprosthesis (CEXC) |
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Applicant | W. L. Gore and Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | MIH |
| Approval date | Dec 22, 2020 |
| Docket number | 20M-2339 |
| Notice date | Dec 23, 2020 |
| Establishment registration | 3007284313 |
| FEI number | 3007284313 |
At a glance
- 10–99 Supplements
- Jul 29, 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- No Withdrawn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: