INTERCEPT Blood System for Platelets

PMA: BP140143 Device Generic Name: Pathogen Reduction System for Platelets Tradename: INTERCEPT Blood System for Platelets Manufacturer: Cerus Corporation Indications: The INTERCEPT Blood System for platelets is intended to be used for ex vivo preparation of pathogen-reduced Amicus apheresis platelet components suspended in 65% PAS-3/35% plasma, and Trima apheresis platelet components suspended in 100% plasma in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD). Product Information Package Insert - INTERCEPT Blood System for Platelets - Small Volume (SV) Processing Set Package Insert - INTERCEPT Blood System for Platelets - Dual Storage (DS) Processing Set Package Insert - INTERCEPT Blood System for Platelets - Large Volume (LV) Processing Set Package Insert - INTERCEPT Blood System for Platelets –Small Volume (SV) Processing Set (Semi-Integrated Set) Package Insert - INTERCEPT Blood System for Platelets –Dual Storage (DS) Processing Set (Semi-Integrated Set) Package Insert - INTERCEPT Blood System for Platelets –Large Volume (LV) Processing Set (Semi-Integrated Set) Supporting Documents November 28, 2025 Approval Letter - INTERCEPT Blood System for Platelets December 19, 2023 Approval Letter - INTERCEPT Blood System for Platelets Supporting Documents older than three years - INTERCEPT Blood System for Platelets