PAT

Bladder System

Product code

PAT

Device name

Bladder System

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

FDA classification definition

for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.

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