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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 NameLIPOSORBER LA-15 SYSTEM
Classification Namelipoprotein, low density, removal
Generic Nameadsorption column
ApplicantKANEKA PHARMA AMERICA LLC
PMA NumberP910018
Supplement NumberS012
Date Received09/11/2006
Decision Date03/31/2009
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the liposorber la-15 system using the ma-03 apheresis machine and the blood tubing systems; nk-m3r and nk-m1r.
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