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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.
 
DeviceH.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
SCHWARZENBERGER WEG 73-79
MELSUNGEN D-342-3421
PMA NumberP940016
Supplement NumberS013
Date Received09/30/2009
Decision Date07/22/2010
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00526058
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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