PMA supplement
P040037 S060: GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA PMA supplement · Panel Track · W. L. Gore & Associates, Inc.
Key facts
| Original PMA | P040037 |
|---|---|
| Supplement number | S060 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE |
| Generic name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Applicant | W. L. Gore & Associates, Inc. |
| Product code | NIP |
| Received date | Dec 2, 2013 |
| Decision date | Sep 19, 2014 |
| Docket number | 14M-1452 |
| Notice date | Oct 14, 2014 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: