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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 NamePLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)
Classification Namelipoprotein, low density, removal
Generic Nameblood line sets for the heparin-induced extracorporeal ldl preciitation system.
ApplicantB. BRAUN MEDICAL, INC.
PMA NumberP940016
Supplement NumberS012
Date Received02/19/2009
Decision Date04/20/2009
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the packaging material in the pouch used for the heparin adsorber component of the device.
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