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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameH.E.L.P. PLASMAT FUTURA SYSTEM
Classification Namelipoprotein, low density, removal
Generic Nameblood line sets for the heparin-induced extracorporeal ldl preciitation system.
ApplicantB. BRAUN AVITUM AG
PMA NumberP940016
Supplement NumberS015
Date Received12/20/2012
Decision Date02/22/2013
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in membrane length and an increase in housing 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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