Product code PAL

Device name

Pulmonic Replacement Heart Valve

Medical specialty

Cardiovascular

Device class

f

Regulation number

870.3925

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

For open surgical replacement of malfunctioning pulmonic heart valve.

Source

FDA openFDA device classification dataset