Implantable Bladder-Evacuation Electrical Stimulation System
ODH · f · Unknown
Classification
FDA Product Code
ODH
Device class
f
Regulation
—
Review panel
GU
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.