Product code
NPV: Pulmonary valve prosthesis percutaneously delivered
FDA product code · HDE · Cardiovascular
Key facts
| Product code | NPV |
|---|---|
| Device | Pulmonary valve prosthesis percutaneously delivered |
| Device class | HDE |
| Review panel | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| Definition | These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 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