PMA supplement
P130029 S002: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
FDA PMA supplement · Panel Track · Bard Peripheral Vascular, Inc.
Key facts
| Original PMA | P130029 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | FLUENCY PLUS ENDOVASCULAR STENT GRAFT |
| Generic name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
| Applicant | Bard Peripheral Vascular, Inc. |
| Product code | PFV |
| Received date | May 1, 2015 |
| Decision date | Apr 26, 2016 |
| Docket number | 16M-1223 |
| Notice date | May 12, 2016 |
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: