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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePAT
Device Class Humanitarian Device Exemption

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