PMA P850020S019

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S019
Product code: LKN
Decision date: 2004-04-14
Generic name: Separator, automated, blood cell and plasma, therapeutic
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.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S019
Product code: LKN
Generic name: Separator, automated, blood cell and plasma, therapeutic
Decision date: 2004-04-14
Decision code: APPR
Date received: 2003-10-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.