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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 CORP.
PMA NumberP910018
Supplement NumberS007
Date Received08/22/2000
Decision Date03/06/2003
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the transfer of the assembly and soldering of printed circuit boards used in conjunction with the final assembly of the ma-01 apheresis machine to yokogawa ibiden components corporaiton, oume-city, tokyo 198 japan.
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