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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameKANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN
Classification Namebeta 2-microglobulin apheresis column
Generic Namebeta 2-microglobulin apheresis column
Applicant
Kaneka Pharma America, LLC
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH130001
Supplement NumberS002
Date Received04/18/2016
Decision Date05/16/2016
Product Code
PDI[ Registered Establishments with PDI ]
Advisory Committee Gastroenterology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Changes at the osaka plant to the method of connecting and disconnecting column housings/filled columns to the processing line, method of replacing fluid in the column, method of removing air in the column and elimination of the air-tightness test of the column due to redundancy. The changes were made to reduce man-hours by introducing automated processes performed by the new machine.
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