PAP

Aortic Heart Valve, More Than Minimally Manipulated Allograft

Product code
PAP
Device name
Aortic Heart Valve, More Than Minimally Manipulated Allograft
Device class
Class F
Medical specialty
Unknown
Marketing pathway
HDE - Humanitarian Device Exemption
Flag
Implant
Flag
Life-sustaining / life-supporting

FDA classification definition

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

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

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