ODH

Implantable Bladder-Evacuation Electrical Stimulation System

Product code

ODH

Device name

Implantable Bladder-Evacuation Electrical Stimulation System

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

FDA classification definition

To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable.

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