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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameLIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
Classification Namelipoprotein, low density, removal
Generic Nameadsorption column
ApplicantKANEKA PHARMA AMERICA CORP.
PMA NumberP910018
Date Received03/26/1991
Decision Date02/21/1996
Product Code
MMY[ Registered Establishments with MMY ]
Docket Number 96M-0193
Notice Date 07/01/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the liposorber la-15 system. The device is a low density lipoprotein (ldl) apheresis sytem.
Supplements: S001 S002 S005 S006 S007 S009 S011 S012 S013 
S015 S016 
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