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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 Nametherapeutic plasma exchange
PMA NumberP850020
Supplement NumberS017
Date Received04/15/2003
Decision Date04/15/2004
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to 1) add a precaution about the use of pediatric aspirin for rheumatoid arthritis (ra) patients due to the increases risk of thrombosis, and 2) specify the treatment regimen for idiopathic thrombocytopenic purpura (itp) patients so that patients receive 6 treatments, 2-3 times a week for 2 or 3 weeks.