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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 NameB.BRAUN,S HEPARIN-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 MEDICAL, INC.
PMA NumberP940016
Supplement NumberS009
Date Received06/07/2002
Decision Date09/20/2002
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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).
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