PROSORBA COLUMN

FDA premarket approval P850020/S019 · decided 2004-04-14

Approval details

PMA number

P850020

Supplement

S019

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Postapproval Study Protocol

Trade name

PROSORBA COLUMN

Generic name

Separator, automated, blood cell and plasma, therapeutic

Applicant

Fresenius Hemocare, Inc.

Date received

2003-10-17

Decision date

2004-04-14

Days to decision

180 days

Decision code

APPR

Product code

LKN

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Waltham, MA

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 INCL