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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrical stimulation bladder system
Definition 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.
Product CodePAZ
Device Class Humanitarian Device Exemption

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