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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultrafiltration-controlled nocturnal dialysate delivery system
Definition Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.
Product CodeODN
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

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