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U.S. Department of Health and Human Services

Product Classification
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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 CodeODH
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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