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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 NumberS019
Date Received10/17/2003
Decision Date04/14/2004
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for several changes to the ra-4 post-approval study protocol. Specifically, these are: 1) a change in inclusion criterion 6 to allow the enrollment of patients who have been on methotrexate (>= 15 mg/week) for at least three months prior to screening, rather than six months prior to screening; 2) the addition of an inclusion criterion to allow the enrollment of patients who have had toxicity to methotrexate at a dose of >= 15 mg/week if they can be on a dose of 12. 5 mg/week; 3) the inclusion of patients receiving concomitant treatment with other disease-modifying anti-rheumatic drugs (dmards); and 4) the inclusion of patients with 12 or more joints tender or painful on motion or pressure, rather than 16 such joints.