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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 ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
Generic NameLipoprotein, low density, removal
ApplicantKANEKA PHARMA AMERICA CORP.
546 FIFTH AVE., 21ST FLOOR
NEW YORK, NY 10036
PMA NumberP910018
Supplement NumberS018
Date Received02/16/2016
Decision Date03/10/2016
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 of vendor (and manufacturing site) of brominated polycarbonate for the housing and header components in the LIPOSORBER LA-15 System’s SULFLUX KP-05.
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