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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device INTERCEPT(R) Blood System for Plasma
Classification Nameilluminator system for blood products
Generic Namepreparation and storage of pathogen-reduced, blood components.
Applicant
Cerus Corporation
1220 concord ave suite 600
Concord , CA 94520 
  
PMA NumberBP130076
Date Received11/29/2013
Decision Date12/16/2014
Decision Approved
Product Code
PJF[ Registered Establishments with PJF ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductYes
Supplements: S002 S020 S021 S029 S031 S032 S033 S034 S035 
S036 S038 S042 S050 S051 S055 S057 S058 S060 
S062 S064 S066 S067 S068 S069 S071 S072 S074 
S075 S077 S078 S079 S081 S083 S086 S091 
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