Product name: Isoplate Solution in 500mL EXCEL containers; Multi-Electrolyte Injection
Manufacturer: B. Braun Medical, Inc.
Intended Use: Isoplate™ Solution Platelet Additive Solution [PAS-F] as an isotonic solution to replace a portion of the plasma to store Platelet Pheresis, Leukocytes Reduced PAS products collected using a hyperconcentrated collection on Terumo BCT’s Trima Accel® System
Approval Date: March 5, 2013
Type of submission: New Drug Application
NDA Number: BN090067/0
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