PAL

Pulmonic Replacement Heart Valve

Product code

PAL

Device name

Pulmonic Replacement Heart Valve

Device class

Class F

21 CFR

21 CFR 870.3925

Medical specialty

Cardiovascular

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

Flag

Life-sustaining / life-supporting

FDA classification definition

For open surgical replacement of malfunctioning pulmonic heart valve.

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