PMA supplement
P040037 S150: GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
FDA PMA supplement · 30-Day Notice · W. L. Gore & Associates, Inc.
Key facts
| Original PMA | P040037 |
|---|---|
| Supplement number | S150 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | W. L. Gore & Associates, Inc. |
| Product code | NIP |
| Received date | Jan 20, 2022 |
| Decision date | Feb 22, 2022 |
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: