PROSORBA(TM) COLUMN

FDA premarket approval P850020/S008 · decided 1996-09-27

Approval details

PMA number

P850020

Supplement

S008

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

PROSORBA(TM) COLUMN

Generic name

Separator, automated, blood cell and plasma, therapeutic

Applicant

Fresenius Hemocare, Inc.

Date received

1994-08-12

Decision date

1996-09-27

Days to decision

777 days

Decision code

APPR

Product code

LKN

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Waltham, MA

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 PATIE