PMA P850020S013

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S013
Product code: LKN
Decision date: 2001-10-26
Generic name: Separator, automated, blood cell and plasma, therapeutic
Approval order statement: APPROVAL FOR REVISED LABELING THAT RELATES NEW POST-MARKET SAFETY INFORMATION REGARDING EPISODES OF VASCULITIS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH THE PROSORBA(R) COLUMN.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S013
Product code: LKN
Generic name: Separator, automated, blood cell and plasma, therapeutic
Decision date: 2001-10-26
Decision code: APPR
Date received: 2001-04-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISED LABELING THAT RELATES NEW POST-MARKET SAFETY INFORMATION REGARDING EPISODES OF VASCULITIS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH THE PROSORBA(R) COLUMN.