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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 for therapeutic purposes, membrane automated blood cell/plasma
Generic Nametherapeutic plasma exchange
PMA NumberP850020
Supplement NumberS024
Date Received09/18/2006
Decision Date10/19/2006
Product Code
MDP[ Registered Establishments with MDP ]
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 add 1) caution and precaution statements relating to the risk of thrombosis, 2) a clarification regarding treatment volumes for idiopathic thrombocytopenic purpura (itp) patients, 3) a clarification that itp, as well as rheumatoid arthritis, patients may not feel the effects of prosorba treatments immediately after initiation of therapy, and 4) a clarification that treatments should begin within one hour of priming.