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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 NumberS031
Date Received06/28/2021
Decision Date07/28/2021
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Introduction of parametric release into the manufacturing process for the LIPOSORBER LA-15 LDL Adsorption Column which is a component device of the LIPOSORBER LA-15 System.
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