NPU
- Product code
- NPU
- Device name
- Prosthesis, Mitral Valve, Percutaneously Delivered
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
FDA classification definition
These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Official FDA classification page: NPU
Classification and pathway per current FDA publications. Data from openFDA (CC0).