PMA supplement
P990009 S069: Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal
FDA PMA supplement · 30-Day Notice · Baxter Healthcare Corp
Key facts
| Original PMA | P990009 |
|---|---|
| Supplement number | S069 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal |
| Generic name | Absorbable collagen hemostatic agent with thrombin |
| Applicant | Baxter Healthcare Corp |
| Product code | PMX |
| Received date | Apr 22, 2022 |
| Decision date | May 20, 2022 |
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: