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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 SYSTEM
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
Schwarzenberger Weg 73-79
Melsungen D-34212
PMA NumberP940016
Supplement NumberS015
Date Received12/20/2012
Decision Date02/22/2013
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN INCREASE IN MEMBRANE LENGTH AND AN INCREASE INHOUSING LENGTH OF THE HEPARIN ADSORBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEPARIN ADSORBER 400 AND IS INDICATED FOR USE AS A COMPONENT OF THE H.E.L.P FUTURA APHERESIS SYSTEM, USED FOR THE REMOVAL, BY IONIC EXCHANGE, OF EXCESS HEPARIN ADDED TO PRECIPITATE LIPOPROTEINS FROM PLASMA.
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