NPU

Prosthesis, Mitral Valve, Percutaneously Delivered

Product code
NPU
Device name
Prosthesis, Mitral Valve, Percutaneously Delivered
Device class
Class 3
Medical specialty
Unknown
Marketing pathway
PMA
Flag
Implant
Flag
Life-sustaining / life-supporting

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NPU
Classification and pathway per current FDA publications. Data from openFDA (CC0).