PMA supplement
P990037 S024: VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
FDA PMA supplement · Panel Track · Vascular Solutions, Inc.
Key facts
| Original PMA | P990037 |
|---|---|
| Supplement number | S024 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT |
| Generic name | Device, hemostasis, vascular |
| Applicant | Vascular Solutions, Inc. |
| Product code | MGB |
| Received date | Jun 22, 2006 |
| Decision date | Dec 22, 2006 |
| Docket number | 07M-0188 |
| Notice date | May 11, 2007 |
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: