PMA supplement
N18286 S036: Gelfoam (absorbable gelatin) Sterile Sponge
FDA PMA supplement · Special (Immediate Track) · Pfizer, Inc.
Key facts
| Original PMA | N18286 |
|---|---|
| Supplement number | S036 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Gelfoam (absorbable gelatin) Sterile Sponge |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Pfizer, Inc. |
| Product code | LMF |
| Received date | Nov 10, 2020 |
| Decision date | Dec 10, 2020 |
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: