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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS031
Date Received03/11/2020
Decision Date12/14/2020
Decision Approved
Product Code
PJF[ Registered Establishments with PJF ]
Advisory Committee Hematology
Supplement Type135 Day Track for 30 Day Notification
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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