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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 NumberS004
Date Received12/15/1998
Decision Date08/12/1999
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
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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