| Device |
implantable bladder-evacuation electrical stimulation system |
| 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. |
| Physical State |
May include: electrodes, implantable pulse gnerator, battery charger, programmer or transmitter, surgical components |
| Technical Method |
electrical sacral nerve stimulation |
| Target Area |
sacral anterior root |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | ODH |
|---|
| Submission Type |
HDE
|
|---|
| Device Class |
3 (De Novo Petitions Granted)
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
