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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 Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
PMA NumberP850020
Supplement NumberS008
Date Received08/12/1994
Decision Date09/27/1996
Product Code
LKN[ Registered Establishments with LKN ]
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 labeling changes to the package insert (i. E. , revisions to the sections entitled column preparation, off-line procedure and on-line procedure, including more detailed instructions for use, illustrations of the device set-up, increased patient monitoring and refinement of specified plasma flow rates) and a procedure change involving the use of an "in-line" leukocyte removal filtr for microaggregate removal which is to be inserted in te blood line returning treated plasma to the patient.