PMA P850020S024

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S024
Product code: MDP
Decision date: 2006-10-19
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement: APPROVAL FOR LABELING CHANGES TO ADD 1) CAUTION AND PRECAUTION STATEMENTS RELATING TO THE RISK OF THROMBOSIS, 2) A CLARIFICATION REGARDING TREATMENT VOLUMES FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS, 3) A CLARIFICATION THAT ITP, AS WELL AS RHEUMATOID ARTHRITIS, PATIENTS MAY NOT FEEL THE EFFECTS OF PROSORBA TREATMENTS IMMEDIATELY AFTER INITIATION OF THERAPY, AND 4) A CLARIFICATION THAT TREATMENTS SHOULD BEGIN WITHIN ONE HOUR OF PRIMING.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S024
Product code: MDP
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date: 2006-10-19
Decision code: APPR
Date received: 2006-09-18
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO ADD 1) CAUTION AND PRECAUTION STATEMENTS RELATING TO THE RISK OF THROMBOSIS, 2) A CLARIFICATION REGARDING TREATMENT VOLUMES FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS, 3) A CLARIFICATION THAT ITP, AS WELL AS RHEUMATOID ARTHRITIS, PATIENTS MAY NOT FEEL THE EFFECTS OF PROSORBA TREATMENTS IMMEDIATELY AFTER INITIATION OF THERAPY, AND 4) A CLARIFICATION THAT TREATMENTS SHOULD BEGIN WITHIN ONE HOUR OF PRIMING.