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U.S. Department of Health and Human Services

Product Classification
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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 CodeQPT
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
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