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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.
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
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.