Product code NPV

Device name

Pulmonary Valve Prosthesis Percutaneously Delivered

Medical specialty

Unknown

Device class

f

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset