ODH — Implantable Bladder-Evacuation Electrical Stimulation System Class f
FDA product code ODH covers "Implantable Bladder-Evacuation Electrical Stimulation System", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- ODH
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- Yes
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.