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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 NumberS036
Date Received05/31/2024
Decision Date01/15/2025
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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