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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
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
Applicant
KANEKA 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[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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