PMA P850020S022

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S022
Product code: MDP
Decision date: 2006-06-22
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 HAEMONETICS MCS AND HAEMONETICS MCS+ PLASMAPHERESIS SYSTEMS IN CONJUNCTION WITH THE PROSORBA COLUMN.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S022
Product code: MDP
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date: 2006-06-22
Decision code: APPR
Date received: 2006-03-31
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 HAEMONETICS MCS AND HAEMONETICS MCS+ PLASMAPHERESIS SYSTEMS IN CONJUNCTION WITH THE PROSORBA COLUMN.