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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.
 
DeviceLIPOSORBER LA-15 SYSTEM
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
Applicant
KANEKA PHARMA AMERICA CORP.
546 fifth ave., 21st floor
new york, NY 10036
PMA NumberP910018
Supplement NumberS011
Date Received04/20/2006
Decision Date06/27/2007
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to use the sulflux kp-05 plasma separator as a component of the liposorber la-15 system.
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