HDE supplement
H130006 S002: FENIX CONTINENCE RESTORATION SYSTEM
FDA HDE supplement · normal 75 day track · TORAX MEDICAL, INC.
Key facts
| Original HDE | H130006 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | FENIX CONTINENCE RESTORATION SYSTEM |
| Generic name | Mechanical compression device fecal incontinence (non-manually operated) |
| Applicant | TORAX MEDICAL, INC. |
| Product code | PMH |
| Received date | Sep 7, 2016 |
| Decision date | Nov 21, 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: