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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 Systerm for Platelets
Classification Nameilluminator system for blood products
Generic Namepreparation and storage of pathogen-reduced, blood components.
Applicant
Cerus Corporation
2550 stanwell drive
Concord , CA 94520 
PMA NumberBP140143
Date Received07/01/2014
Decision Date12/18/2014
Decision Approved
Product Code
PJF[ Registered Establishments with PJF ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductYes
Supplements: S003 S008 S251 S322 S325 S327 S386 S422 S424 
S425 S426 S450 S453 S454 S455 S493 S495 S497 
S498 S499 S500 S501 S502 S605 S608 S715 S717 
S720 S747 S748 S749 S750 S751 S754 S755 S790 
S791 S815 S816 S856 S858 S859 S860 S863 S930 
S931 S937 1098 1152 1207 
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