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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION ("H.E.L.P.") SYSTEM
Classification Namelipoprotein, low density, removal
Generic Nameblood line sets for the heparin-induced extracorporeal ldl preciitation system.
ApplicantB. BRAUN OF AMERICA, INC.
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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