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INTERCEPT Blood System for Plasma

PMA: BP130076
Device Generic Name: Pathogen Reduction System for Plasma
Tradename: INTERCEPT Blood System for Plasma
Manufacturer: Cerus Corporation
Indications:

  • The INTERCEPT Blood System for Cryoprecipitation is intended to provide a functionally closed system for the production of Pathogen Reduced Plasma, Cryoprecipitate Reduced.
    • Pathogen Reduced Plasma, Cryoprecipitate Reduced is indicated for transfusion or therapeutic plasma exchange (TPE) in patients with thrombotic thrombocytopenic purpura (TTP).
    • It may be used to provide coagulation factors, except fibrinogen, factor VIII, factor XIII, and von Willebrand factor (vWF), for transfusion support of patients with appropriate clinical indications.
  • The INTERCEPT Blood System for Cryoprecipitation is intended to provide a functionally closed system for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex.
    Pathogen Reduced Cryoprecipitated Fibrinogen Complex is indicated for:
    • Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
    • Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available.
    • Second-line therapy for von Willebrand disease (vWD).
    • Control of uremic bleeding after other treatment modalities have failed.

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