www.fdanews.com/articles/181896-emed-technologies-wins-expanded-indication-for-syringe-infusion-system
EMED Technologies Wins Expanded Indication for Syringe Infusion System
May 23, 2017
EMED Technologies has been granted expanded indications on its FDA-cleared SCIg60 infusion system.
The device administers human plasma-derived immunoglobulin biologics.
The SCIg60 relied upon drug-device compatibility validation for use, which includes subcutaneous infusions of Cuvitru, Gammagard liquid and Hizentra.
The FDA created a new device code “PKP” to classify and regulate infusion systems for immunoglobulins. — Cynthia Jessup