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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Composed of four components: a pair of paheresis columns (dextran sulfate cellulose adsorption column soaked in sodium citrate solution); two other disposabel components (a hollow fiber, ethylene vinyl alcohol copolymer-coated polyethylene plasma spearator and a polyvinyl chloride tubing system); and a reusable electronic control unit.
Technical Method Blood is pumped from patients arm into the device which then separates blood into cellular components and plasma. Plasma is then sent thru dextran sulfate cellulose column to remove specific plasma components. Depleted plasma is then recombined with cellular blood elements and is then pumped back to patient.
Target Area Plasma components are removed to aid the patients kidneys
Review Panel Gastroenterology/Urology
Product CodePBN
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible