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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apheresis for focal glomerulosclerosis in pediatric patients
Definition Teatment of pediatric patients with primary focal segmental glomerulosclerosis in which standard treatment options are unsuccessful or not well tolerated or treatment of post renal transplantation pediatric patients with recurring primary focal segmental glomerulosclerosis
Product CodePBN
Device Class Humanitarian Device Exemption