HDE
H990002: EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
FDA Humanitarian Device Exemption · GENZYME CORP.
Key facts
| HDE number | H990002 |
|---|---|
| Trade name | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) |
| Generic name | Cultured epithelial autograft |
| Applicant | GENZYME CORP. |
| Owner/operator | GENZYME CORPORATION |
| Product code | OCE |
| Approval date | Oct 25, 2007 |
| Docket number | 07M-0415 |
| Notice date | Nov 7, 2007 |
| Establishment registration | 1220423 |
| FEI number | 1220423 |
At a glance
- 10–99 Supplements
- Feb 4, 2016 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: