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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROSORBA(TM) COLUMN
Generic NameSeparator, automated, blood cell and plasma, therapeutic
ApplicantFRESENIUS HEMOCARE, INC.
920 WINTER STREET
WALTHAM, MA 02451
PMA NumberP850020
Supplement NumberS008
Date Received08/12/1994
Decision Date09/27/1996
Withdrawal Date 04/14/2008
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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
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