PMA supplement
P990009 S053: Floseal NT
FDA PMA supplement · Real-Time Process · Baxter Healthcare Corp
Key facts
| Original PMA | P990009 |
|---|---|
| Supplement number | S053 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Floseal NT |
| Generic name | Absorbable collagen hemostatic agent with thrombin |
| Applicant | Baxter Healthcare Corp |
| Product code | PMX |
| Received date | Jan 22, 2019 |
| Decision date | Apr 18, 2019 |
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: