Device |
stimulator, tibial, electrical, implantable, for urinary incontinence |
Definition |
Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve. |
Physical State |
Stimulator, including power source, implanted to stimulate tibial nerve |
Technical Method |
Uses electrical stimulation of the tibial nerve to interfere with pelvic innervation signals to the bladder |
Target Area |
Implanted adjacent to tibial nerve near malleolus of ankle; stimulation of tibial nerve interferes with pelvic innervation of bladder |
Review Panel |
Gastroenterology/Urology |
Product Code | QPT |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|