PMA P910018S017

Device: LIPOSORBER LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S017
Product code: MMY
Decision date: 2015-07-15
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
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.

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S017
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2015-07-15
Decision code: APPR
Date received: 2015-04-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.