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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 NameLIPOSORBER® LA-15 System
Classification Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Generic Nameapheresis for focal glomerulosclerosis in adult and pediatric patients
Applicant
Kaneka Pharma America, LLC
546 fifth ave., 21st floor
new york, NY 10036
HDE NumberH170002
Supplement NumberS013
Date Received05/31/2024
Decision Date01/15/2025
Product Code
PBN[ Registered Establishments with PBN ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Relocation of manufacturing site to kaneka corporation tomatoh plant 6-253, kashiwabara, tomakomai-shi, hokkaido, japan. Fei 3031408734.
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