PMA supplement
P050006 S002: GORE HELEX SEPTAL OCCLUDER
FDA PMA supplement · Normal 180 Day Track No User Fee · W. L. Gore & Associates, Inc.
Key facts
| Original PMA | P050006 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | GORE HELEX SEPTAL OCCLUDER |
| Generic name | Transcatheter septal occluder |
| Applicant | W. L. Gore & Associates, Inc. |
| Product code | MLV |
| Received date | Oct 16, 2006 |
| Decision date | Dec 13, 2006 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: