PMA
P050006: GORE HELEX SEPTAL OCCLUDER
FDA PMA · Transcatheter septal occluder · W. L. Gore & Associates, Inc.
Key facts
| PMA number | P050006 |
|---|---|
| Trade name | GORE HELEX SEPTAL OCCLUDER |
| Generic name | Transcatheter septal occluder |
| Applicant | W. L. Gore & Associates, Inc. |
| Owner/operator | W. L. GORE & ASSOCIATES, INC. |
| Product code | MLV |
| Approval date | Aug 11, 2006 |
| Docket number | 06M-0341 |
| Notice date | Aug 25, 2006 |
| Establishment registration | 2017233 |
| FEI number | 2017233 |
At a glance
- 100–999 Supplements
- Aug 3, 2026 Latest supplement decision
- No Withdrawn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: