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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
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
Applicant
B. Braun Avitum AG
schwarzenberger weg 73-79
melsungen D-342-3421
PMA NumberP940016
Supplement NumberS001
Date Received11/02/1998
Decision Date04/26/1999
Product Code
MMY[ Registered Establishments with MMY ]
Docket Number N
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter.
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