Product code PAP

Device name

Aortic Heart Valve, More Than Minimally Manipulated Allograft

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

Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.

Source

FDA openFDA device classification dataset