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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.
Classification Namelipoprotein, low density, removal
Generic Nameadsorption column
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 - component
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.