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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.
 
DeviceB.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
SCHWARZENBERGER WEG 73-79
MELSUNGEN D-342-3421
PMA NumberP940016
Supplement NumberS009
Date Received06/07/2002
Decision Date09/20/2002
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) THE TRANSFER OF THE STERILIZATION PROCESS FOR THE BLOOD TUBING LINE COMPONENT OF B. BRAUN MEDICAL, INC.'S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM FROM ITS CURRENT, PMA APPROVED LOCATION TO THE B. BRAUN CAREX S.P.A. FACILITY; AND 2) THE PROPOSAL TO STERILIZE THE BLOOD TUBING LINES USING 10 PERCENT ETHYLENE OXIDE (ETO) AND 90 PERCENT CARBON DIOXIDE (CO2).
Post-Approval StudyShow Report Schedule and Study Progress
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