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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 NumberS040
Date Received08/30/2024
Decision Date09/26/2024
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  
Change in synthesis tank, timing of column bioburden reduction operation, and process automation including gel transfer operation, adjustment operation for gell filling volume, cap attachment operation, appearance inspection for final product release, transfer of intermediate products between processes.
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