| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | PROSORBA COLUMN |
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| Generic Name | Separator, automated, blood cell and plasma, therapeutic |
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| Applicant | Fresenius Hemocare, Inc.
920 Winter St.
Waltham, MA 02451 |
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| PMA Number | P850020 |
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| Supplement Number | S019 |
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| Date Received | 10/17/2003 |
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| Decision Date | 04/14/2004 |
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| Withdrawal Date | 04/14/2008 |
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| Product Code |
LKN |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Postapproval Study Protocol |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
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