PMA supplement
P990009 S077: Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma
FDA PMA supplement · 30-Day Notice · Baxter Healthcare Corp
Key facts
| Original PMA | P990009 |
|---|---|
| Supplement number | S077 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma |
| Generic name | Absorbable collagen hemostatic agent with thrombin |
| Applicant | Baxter Healthcare Corp |
| Product code | PMX |
| Received date | Oct 10, 2025 |
| Decision date | Nov 13, 2025 |
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: