PMA P850020S021

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S021
Product code: LKN
Decision date: 2005-08-25
Generic name: Separator, automated, blood cell and plasma, therapeutic
Approval order statement: APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE ART HEMOADSORPTION SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S021
Product code: LKN
Generic name: Separator, automated, blood cell and plasma, therapeutic
Decision date: 2005-08-25
Decision code: APPR
Date received: 2005-07-26
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE ART HEMOADSORPTION SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.