FDA product code PMH: Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)
PMH is the FDA product code for mechanical compression device fecal incontinence (non-manually operated). It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under PMH reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For treatment of fecal incontinence in patients who have failed conservative therapies
Classification
| Field | Value |
|---|---|
| Device name | Mechanical Compression Device Fecal Incontinence (Non-Manually Operated) |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for PMH devices
openFDA lists no recalls for product code PMH.
Frequently asked questions
What is FDA product code PMH?
PMH is the FDA product code for mechanical compression device fecal incontinence (non-manually operated). It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is PMH?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PMH
- Run a recall and safety report across every PMH manufacturer
- Watch product code PMH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times