||electrical stimulation bladder system|
||For the treatment of patients who have complete spinal cord lesions (asia classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation.
||Implantable Receiver-Stimulator, and Extradural Electrodes; External controller (battery powered), External Transmitter, Battery Charger, Power Cord, External Cable and Transmitter Tester; Surgical component -Surgical stimulator, Extradural Surgical Probe, Intradural Surgical Probe, Electrode test Cable and Silicone adhesive.
||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.
||Electrical stimulation of the lower bowel in the GI Tract to provide fecal evacuation on demand.
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Urology and Lithotripsy Devices Branch (ULDB)
HDE - Humanitarian Device Exemption
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible