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U.S. Department of Health and Human Services

Product Classification

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Device bladder system
Definition for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.
Physical State Implantable Receiver-Stimulator, and Extradural Electrodes; External controller (battery powered), External Transmitter, Battery Charger, Power Corc, External Cable and Transmitter Tester; Surgical component -Surgical stimulator, Extradural Surgical Probe, Intradural Surgical Probe, Electrode test Cable and Silicone adhesive.
Technical Method Sacral anterior root stimulator intended to provide bladder evacuation by delivering electrical stimulation to the patient's intact spinal nerve root in order to elicit functional contraction of the muscles innervated by them. It consists of implantable, external, and surgical components.
Target Area Electrical stimulation of the urinary bladder in the Gu Tract to provide urination on demand and to reduce post-void residual volumes of urine.
Review Panel Gastroenterology/Urology
Product CodePAT
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible