Product code
PMH: Mechanical compression device fecal incontinence (non-manually operated)
FDA product code · HDE · Gastroenterology/Urology
Key facts
| Product code | PMH |
|---|---|
| Device | Mechanical compression device fecal incontinence (non-manually operated) |
| Device class | HDE |
| Review panel | Gastroenterology/Urology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | For treatment of fecal incontinence in patients who have failed conservative therapies |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database