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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 LA-15 SYSTEM
Generic NameLipoprotein, low density, removal
ApplicantKaneka Pharma America Corp.
546 Fifth Ave., 21st Floor
New York, NY 10036
PMA NumberP910018
Supplement NumberS001
Date Received11/02/1998
Decision Date10/29/1999
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following changes: 1) replacing the Membrane Filter Unit (MFU) located in the Liposorber LA-15 adsorption column, with the Cardioplegia Supor-1220 filter, which is bonded to the Extracoporeal Blood Tubing System, LT-MA2; 2) removing the maintenance unit and adding a clamp valve cover plate to the MA-01 Apheresis Unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer for the patients; and, 4) revising the Operators' Manual to incorporate the revisions associated with the hardware and software changes.
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