PMA
N18286: GELFOAM
FDA PMA · Agent, absorbable hemostatic, collagen based · Pfizer, Inc.
Key facts
| PMA number | N18286 |
|---|---|
| Trade name | GELFOAM |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Pfizer, Inc. |
| Owner/operator | PFIZER INC. |
| Product code | LMF |
| Approval date | Jul 8, 1983 |
| Docket number | 83M-0243 |
| Notice date | Aug 29, 1983 |
| Establishment registration | 3009712172 |
| FEI number | 3009712172 |
At a glance
- 10–99 Supplements
- May 16, 2023 Latest supplement decision
- No Withdrawn
- No 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: