HDE supplement
H020004 S002: DERMAGRAFT (DYSTROPHIC EPIDERMOLYSIS BULLOSA)
FDA HDE supplement · normal 75 day track · ADVANCED BIOHEALING, INC
Key facts
| Original HDE | H020004 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | DERMAGRAFT (DYSTROPHIC EPIDERMOLYSIS BULLOSA) |
| Generic name | Dressing, wound and burn, interactive |
| Applicant | ADVANCED BIOHEALING, INC |
| Product code | MGR |
| Received date | Jun 13, 2006 |
| Decision date | Aug 9, 2006 |
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: