PMA P850020S017

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S017
Product code: LKN
Decision date: 2004-04-15
Generic name: Separator, automated, blood cell and plasma, therapeutic
Approval order statement: APPROVAL FOR LABELING CHANGES TO 1) ADD A PRECAUTION ABOUT THE USE OF PEDIATRIC ASPIRIN FOR RHEUMATOID ARTHRITIS (RA) PATIENTS DUE TO THE INCREASES RISK OF THROMBOSIS, AND 2) SPECIFY THE TREATMENT REGIMEN FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS SO THAT PATIENTS RECEIVE 6 TREATMENTS, 2-3 TIMES A WEEK FOR 2 OR 3 WEEKS.

Current openFDA PMA Record#

Device: PROSORBA COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S017
Product code: LKN
Generic name: Separator, automated, blood cell and plasma, therapeutic
Decision date: 2004-04-15
Decision code: APPR
Date received: 2003-04-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO 1) ADD A PRECAUTION ABOUT THE USE OF PEDIATRIC ASPIRIN FOR RHEUMATOID ARTHRITIS (RA) PATIENTS DUE TO THE INCREASES RISK OF THROMBOSIS, AND 2) SPECIFY THE TREATMENT REGIMEN FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS SO THAT PATIENTS RECEIVE 6 TREATMENTS, 2-3 TIMES A WEEK FOR 2 OR 3 WEEKS.