PMA P940016S013

Device: H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S013
Product code: MMY
Decision date: 2010-07-22
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: APPROVAL FOR DESIGN MODIFICATIONS TO THE PLASMAT SECURA SYSTEM INCLUDING THE USE OF THE PLASMAT FUTURA MACHINE WITH SOFTWARE VERSION 2.6.01, THE FUTURA KIT, AND INDIVIDUALLY PACKAGED COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM AND IS INDICATED FOR ACUTELY REMOVING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (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:GROUP A: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; GROUP B: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 300 MG/DL; AND GROUP C: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 200 MG/DL AND DOCUMENTED CORONARY ARTERY DISEASE.

Current openFDA PMA Record#

Device: H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S013
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2010-07-22
Decision code: APPR
Date received: 2009-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN MODIFICATIONS TO THE PLASMAT SECURA SYSTEM INCLUDING THE USE OF THE PLASMAT FUTURA MACHINE WITH SOFTWARE VERSION 2.6.01, THE FUTURA KIT, AND INDIVIDUALLY PACKAGED COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM AND IS INDICATED FOR ACUTELY REMOVING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (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:GROUP A: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; GROUP B: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 300 MG/DL; AND GROUP C: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 200 MG/DL AND DOCUMENTED CORONARY ARTERY DISEASE.