PAPHumanitarian device exemption

Aortic Heart Valve, More Than Minimally Manipulated Allograft

Unknown

PAP is the FDA product code for Aortic Heart Valve, More Than Minimally Manipulated Allograft. FDA's definition for this code reads: "Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PAP
Device name: Aortic Heart Valve, More Than Minimally Manipulated Allograft
FDA definition: Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: Yes
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PAP.

Recent clearances

Product code PAP

FDA records hold no clearances under product code PAP.

Recent recalls

Product code PAP

FDA records show no recalls under product code PAP.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)