FDA product code NPV: Pulmonary Valve Prosthesis Percutaneously Delivered
NPV is the FDA product code for pulmonary valve prosthesis percutaneously delivered. It is a HDE device, reviewed by the Cardiovascular panel. Devices under NPV reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 2 recalls for NPV devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NPV devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-05-22.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NPV?
NPV is the FDA product code for pulmonary valve prosthesis percutaneously delivered. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is NPV?
HDE. Typical premarket route: PMA.
Have NPV devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NPV
- Run a recall and safety report across every NPV manufacturer
- Watch product code NPV 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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