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