PMA P850020S023

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S023
Product code: MDP
Decision date: 2006-05-11
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement: APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE COBE SPECTRA APHERESIS SYSTEM AND THE FRESENIUS AS104 SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S023
Product code: MDP
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date: 2006-05-11
Decision code: APPR
Date received: 2006-04-14
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 COBE SPECTRA APHERESIS SYSTEM AND THE FRESENIUS AS104 SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.