NPV — Pulmonary Valve Prosthesis Percutaneously Delivered Class f
FDA product code NPV covers "Pulmonary Valve Prosthesis Percutaneously Delivered", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- NPV
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- 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.