Product code NPW

Device name

Percutaneously Delivered Prostheses And Tricuspid Valves

Medical specialty

Unknown

Device class

3

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

These devices are intended to replace a patient's tricuspid 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.

Source

FDA openFDA device classification dataset