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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.
 
DevicePLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)
Generic NameLipoprotein, low density, removal
ApplicantB. Braun Avitum AG
Schwarzenberger Weg 73-79
Melsungen D-34212
PMA NumberP940016
Supplement NumberS012
Date Received02/19/2009
Decision Date04/20/2009
Product Code MMY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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