FDA Clears All-in-One Reconstitution/Administration Syringe for Xyntha Information from Industry Four experts review metastatic GIST case Connect with the GIST Exchange to view a new program on diagnosising and treating metastatic progressive gastrointestinal stromal tumors (GIST) in a 55-year-old male. Review case study August 10, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a device (Prefilled Dual-Chamber Syringe; Pfizer, Inc) used to reconstitute and administer antihemophilic factor (recombinant) plasma/albumin-free intravenous infusion (Xyntha; Pfizer) in patients with hemophilia A. The all-in-one syringe is the first to supply freeze-dried albumin-free recombinant factor VIII and also the diluent (0.9% sodium chloride), thereby eliminating the reconstitution transfer step and improving patient convenience.
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FDA Clears All-in-One Reconstitution/Administration Syringe for Xyntha