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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
920 winter street
waltham, MA 02451
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.