Product code PAZ

Device name

Electrical Stimulation Bladder System

Medical specialty

Unknown

Device class

f

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation.

Source

FDA openFDA device classification dataset