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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-342-3421
PMA NumberP940016
Supplement NumberS020
Date Received11/02/2015
Decision Date03/17/2016
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
Approval Order Statement  
Approval for a change in manufacturer for your sodium chloride and acetate buffer solution bags.
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