Product code
MWH: Pulmonic valved conduit
FDA product code · HDE · Cardiovascular
Key facts
| Product code | MWH |
|---|---|
| Device | Pulmonic valved conduit |
| Device class | HDE |
| Review panel | Cardiovascular |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 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