HDE supplement
H990002 S013: EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
FDA HDE supplement · normal 75 day track · GENZYME CORP.
Key facts
| Original HDE | H990002 |
|---|---|
| Supplement number | S013 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) |
| Generic name | Cultured epithelial autograft |
| Applicant | GENZYME CORP. |
| Product code | OCE |
| Received date | Oct 19, 2011 |
| Decision date | Feb 4, 2016 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: