PMA
P990004: SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
FDA PMA · Agent, absorbable hemostatic, collagen based · Ferrosan Meidcal Devices A/S
Key facts
| PMA number | P990004 |
|---|---|
| Trade name | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Ferrosan Meidcal Devices A/S |
| Owner/operator | Ferrosan Medical Devices A/S |
| Product code | LMF |
| Approval date | Sep 30, 1999 |
| Docket number | 99M-4776 |
| Establishment registration | 3008478369 |
| FEI number | 3008478369 |
At a glance
- 10–99 Supplements
- Sep 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: