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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 NumberS001
Date Received04/02/2015
Decision Date08/24/2015
Product Code
PDI[ Registered Establishments with PDI ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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