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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. Futura Apheresis System
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
Schwarzenberger Weg 73-79
Melsungen D-34212
PMA NumberP940016
Supplement NumberS027
Date Received09/28/2018
Decision Date06/07/2019
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in the cutting process in the manufacturing of the H.E.L.P. Ultrafilter HI PS 20 included in the H.E.L.P. Futura Set.
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