PMA supplement
P130006 S102: GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
FDA PMA supplement · Real-Time Process · W. L. Gore & Associates, Inc.
Key facts
| Original PMA | P130006 |
|---|---|
| Supplement number | S102 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | W. L. Gore & Associates, Inc. |
| Product code | PFV |
| Received date | Nov 15, 2023 |
| Decision date | Jan 3, 2024 |
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: