PMA P850020S008

Device: PROSORBA(TM) COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S008
Product code: LKN
Decision date: 1996-09-27
Generic name: Separator, automated, blood cell and plasma, therapeutic
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT (I.E., REVISIONS TO THE SECTIONS ENTITLED COLUMN PREPARATION, OFF-LINE PROCEDURE AND ON-LINE PROCEDURE, INCLUDING MORE DETAILED INSTRUCTIONS FOR USE, ILLUSTRATIONS OF THE DEVICE SET-UP, INCREASED PATIENT MONITORING AND REFINEMENT OF SPECIFIED PLASMA FLOW RATES) AND A PROCEDURE CHANGE INVOLVING THE USE OF AN "IN-LINE" LEUKOCYTE REMOVAL FILTR FOR MICROAGGREGATE REMOVAL WHICH IS TO BE INSERTED IN TE BLOOD LINE RETURNING TREATED PLASMA TO THE PATIENT

Current openFDA PMA Record#

Device: PROSORBA(TM) COLUMN
Applicant: Fresenius Hemocare, Inc.
PMA number: P850020
Supplement: S008
Product code: LKN
Generic name: Separator, automated, blood cell and plasma, therapeutic
Decision date: 1996-09-27
Decision code: APPR
Date received: 1994-08-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT (I.E., REVISIONS TO THE SECTIONS ENTITLED COLUMN PREPARATION, OFF-LINE PROCEDURE AND ON-LINE PROCEDURE, INCLUDING MORE DETAILED INSTRUCTIONS FOR USE, ILLUSTRATIONS OF THE DEVICE SET-UP, INCREASED PATIENT MONITORING AND REFINEMENT OF SPECIFIED PLASMA FLOW RATES) AND A PROCEDURE CHANGE INVOLVING THE USE OF AN "IN-LINE" LEUKOCYTE REMOVAL FILTR FOR MICROAGGREGATE REMOVAL WHICH IS TO BE INSERTED IN TE BLOOD LINE RETURNING TREATED PLASMA TO THE PATIENT