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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 NumberS017
Date Received04/10/2015
Decision Date07/15/2015
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
Approval Order Statement  
APPROVAL FOR A MODIFICATION OF THE INDICATIONS FOR USE OF THE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIPOSORBER® LA-15 SYSTEM AND IS INDICATED FOR USE IN PERFORMING LOW DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) APHERESIS TO ACUTELY REMOVE LDL-C FROM THE PLASMA OF THE FOLLOWING HIGH RISK PATIENT POPULATIONS FOR WHOM DIET HAS BEEN INEFFECTIVE AND MAXIMUM DRUG THERAPY HAS EITHER BEEN INEFFECTIVE OR NOT TOLERATED: 1) GROUP A FUNCTIONAL HYPERCHOLESTEROLEMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; 2) GROUP B FUNCTIONAL HYPERCHOLESTEROLEMIC HETEROZYGOTES WITH LDL-C >= 300 MG/DL; AND 3) GROUP C FUNCTIONAL HYPERCHOLESTEROLEMIC HETEROZYGOTES WITH LDL-C >= 160 MG/DL AND DOCUMENTED CORONARY HEART DISEASE.
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