PALHumanitarian device exemption

Pulmonic Replacement Heart Valve

21 CFR 870.3925 / Cardiovascular

PAL is the FDA product code for Pulmonic Replacement Heart Valve, regulated under 21 CFR 870.3925. FDA's definition for this code reads: "For open surgical replacement of malfunctioning pulmonic heart valve". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PAL
Device name: Pulmonic Replacement Heart Valve
FDA definition: For open surgical replacement of malfunctioning pulmonic heart valve.
Regulation: 21 CFR 870.3925
Device class: Humanitarian device exemption
Review panel: Cardiovascular
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 PAL.

Recent clearances

Product code PAL

FDA records hold no clearances under product code PAL.

Recent recalls

Product code PAL

FDA records show no recalls under product code PAL.

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)