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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 NumberS027
Date Received08/13/2019
Decision Date04/21/2020
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modification to the indications for use statement to include a new Group D - "Functional Hypercholesterolemic Heterozygotes with LDL-C >= 100 mg/dl and lipoprotein(a) [Lp(a)] >= 60 mg/dL, and either documented coronary artery disease or documented peripheral artery disease."
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