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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeODH
Device Class Humanitarian Device Exemption

Device Problems
Inappropriate shock 1
Total Device Problems 1

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