HDE supplement
H130006 S001: FENIX CONTINENCE RESTORATION SYSTEM
FDA HDE supplement · normal 75 day track · TORAX MEDICAL, INC.
Key facts
| Original HDE | H130006 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | FENIX CONTINENCE RESTORATION SYSTEM |
| Generic name | Implanted fecal incontinence device |
| Applicant | TORAX MEDICAL, INC. |
| Product code | MIP |
| Received date | Jan 11, 2016 |
| Decision date | Jun 10, 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: