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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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.
 
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
Date Received02/01/2013
Decision Date03/05/2015
Product Code
PDI[ Registered Establishments with PDI ]
Docket Number 15M-0909
Notice Date 03/19/2015
Advisory Committee Gastroenterology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the lixelle® ß2-microglobulin apheresis column (also called the beta2-microglobulin apheresis column or ß2m). This device is indicated for the treatment of patients with clinically diagnosed dialysis-related amyloidosis (dra).
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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