PMA supplement
N18286 S012: GELFOAM STERILE POWDER
FDA PMA supplement · Panel Track · Pfizer, Inc.
Key facts
| Original PMA | N18286 |
|---|---|
| Supplement number | S012 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GELFOAM STERILE POWDER |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Pfizer, Inc. |
| Product code | LMF |
| Received date | Dec 8, 1999 |
| Decision date | Oct 16, 2000 |
| Docket number | 00M-1616 |
| Notice date | Nov 15, 2000 |
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: