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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.
 
DeviceHEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
Schwarzenberger Weg 73-79
Melsungen D-34212
PMA NumberP940016
Supplement NumberS021
Date Received06/13/2016
Decision Date09/09/2016
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes in primary packaging of the H.E.L.P. Futura Set and individually packed filters.
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