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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.
 
DeviceHEPARIN-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 NumberS004
Date Received12/15/1998
Decision Date08/12/1999
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for administering the SF-36 quality of life (QOL) survey on an annual basis, instead of on a quarterly basis, of rthe patient registry/post approval study of the H.E.L.P. System.
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