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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 Namelipoprotein, low density, removal
546 fifth ave., 21st floor
new york, NY 10036
PMA NumberP910018
Supplement NumberS005
Date Received06/20/2000
Decision Date12/06/2000
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 1) replacing the sterilization date with the actual expiration date, expressed as month and year, for the liposorber(r) la-15 system components: liposorber(r) la-15 column, sulflux(r) fs-05 plasma separator, and the tubing sytem for plasmapheresis lt-ma2; 2) replacing the slip-type male tubing connectors with luer-lock type connectors on the separator end-caps of te sulflux fs-05 plasma separator; 3) making the following changes to the tubing system for the plasmapheresis lt-ma2: a) providing sterile transducer protective filters (found substantially equivalent under 510(k) k983076) in packages of ten; b) reducing the number of connection tubes from ten to eight, adding pinch clips and reducing the sharpness of the plastic spike on each end of the connection tube; c) replacing the stainless steel needles, used to connect each infusion line to a bag or bottle of saline or regeneration fluid, with plastic spikes; d) adding a luer-lock "male" and "female" connector to the end of the waste lines; e) increasing the length of the tubing section between the blood pump and chanber level 1 from 80 mm to 90 mm and the length of the tubing section between the waste drip chamber and a "t" dconnector on the waste line from 35 m to 50 mm; and f) adding an infusion line.