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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIPOSORBER LA-15 System
Generic NameLipoprotein, low density, removal
ApplicantKANEKA PHARMA AMERICA CORP.
546 FIFTH AVE., 21ST FLOOR
NEW YORK, NY 10036
PMA NumberP910018
Supplement NumberS033
Date Received03/30/2022
Decision Date04/29/2022
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Qualification of new equipment for the EVOH coating process and the Hollow Fiber (HF) drying process to increase hollow fiber production capacity.
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