HDE
H130006: FENIX CONTINENCE RESTORATION SYSTEM
FDA Humanitarian Device Exemption · TORAX MEDICAL, INC.
Key facts
| HDE number | H130006 |
|---|---|
| Trade name | FENIX CONTINENCE RESTORATION SYSTEM |
| Generic name | Mechanical compression device fecal incontinence (non-manually operated) |
| Applicant | TORAX MEDICAL, INC. |
| Owner/operator | Torax Medical Inc. |
| Product code | PMH |
| Approval date | Dec 18, 2015 |
| Docket number | 15M-4050 |
| Notice date | Mar 3, 2016 |
| Establishment registration | 3008766073 |
| FEI number | 3008766073 |
At a glance
- 1–9 Supplements
- Dec 1, 2016 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 10–99 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: