FDA product code NPU: Prosthesis, Mitral Valve, Percutaneously Delivered
NPU is the FDA product code for prosthesis, mitral valve, percutaneously delivered. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NPU reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Mitral Valve, Percutaneously Delivered |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NPU devices
openFDA lists no recalls for product code NPU.
Frequently asked questions
What is FDA product code NPU?
NPU is the FDA product code for prosthesis, mitral valve, percutaneously delivered. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NPU?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NPU
- Run a recall and safety report across every NPU manufacturer
- Watch product code NPU 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.
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