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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIPOSORBER(R) LA-15 SYSTEM
Generic NameLipoprotein, low density, removal
ApplicantKANEKA PHARMA AMERICA CORP.
546 FIFTH AVE., 21ST FLOOR
NEW YORK, NY 10036
PMA NumberP910018
Supplement NumberS006
Date Received08/07/2000
Decision Date08/21/2000
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE STERILIZATION PROCESS EQUIPMENT FOR THE PLASMAPHERESIS(R) LT-MA2 TUBING SYSTEM THAT IS USED WITH THE LIPOSORBER(R) LA-15 SYSTEM.
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