PMA supplement
N18286 S041: GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP),
FDA PMA supplement · 30-Day Notice · Pfizer, Inc.
Key facts
| Original PMA | N18286 |
|---|---|
| Supplement number | S041 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Pfizer, Inc. |
| Product code | LMF |
| Received date | Apr 25, 2023 |
| Decision date | May 16, 2023 |
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: