FDA product code NPS: Tricuspid Valve Repair Device, Percutaneously Delivered
NPS is the FDA product code for tricuspid valve repair device, percutaneously delivered. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NPS reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation.
Classification
| Field | Value |
|---|---|
| Device name | Tricuspid Valve Repair Device, 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 NPS devices
openFDA lists no recalls for product code NPS.
Frequently asked questions
What is FDA product code NPS?
NPS is the FDA product code for tricuspid valve repair device, percutaneously delivered. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NPS?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NPS
- Run a recall and safety report across every NPS manufacturer
- Watch product code NPS 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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