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.

Product Information

• Package Insert - INTERCEPT Blood System for Cryoprecipitation Reduced Plasma, Cryoprecipitate Reduced
• Package Insert - INTERCEPT Blood System for Cryoprecipitated Fibrinogen Complex

Supporting Documents

• November 24, 2020 Approval Order - INTERCEPT Blood System for Plasma
• May 1, 2020 Approval Order - INTERCEPT Blood System for Plasma
• Supporting Documents older than three years - INTERCEPT Blood System for Plasma