Product code ODH
- Device name
- Implantable Bladder-Evacuation Electrical Stimulation 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
- 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.
- Source
- FDA openFDA device classification dataset