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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 NumberS023
Date Received06/08/2017
Decision Date07/06/2017
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Qualification of an additional clean room area for the B. Braun Avitum Italy Plant for the manufacturing of the H.E.L.P Futura Set.
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