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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.
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
546 fifth ave., 21st floor
new york, NY 10036
PMA NumberP910018
Supplement NumberS001
Date Received11/02/1998
Decision Date10/29/1999
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.