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. |
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Device | PROSORBA(TM) COLUMN |
Generic Name | Separator, automated, blood cell and plasma, therapeutic |
Applicant | FRESENIUS HEMOCARE, INC. 920 WINTER STREET WALTHAM, MA 02451 |
PMA Number | P850020 |
Supplement Number | S008 |
Date Received | 08/12/1994 |
Decision Date | 09/27/1996 |
Withdrawal Date
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04/14/2008 |
Product Code |
LKN |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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