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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.
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
B. Braun Avitum AG
schwarzenberger weg 73-79
melsungen D-342-3421
PMA NumberP940016
Supplement NumberS013
Date Received09/30/2009
Decision Date07/22/2010
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT00526058
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications to the plasmat secura system including the use of the plasmat futura machine with software version 2. 6. 01, the futura kit, and individually packaged components. The device, as modified, will be marketed under the trade name h. E. L. P. Plasmat futura apheresis system and is indicated for acutely removing low-density lipoprotein cholesterol (ldl-c) from the plasma of the following high-risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated:group a: functional hypocholesterol-emic homozygotes with ldl-c > 500 mg/dl; group b: functional hypocholesterol-emic homozygotes with ldl-c > 300 mg/dl; and group c: functional hypocholesterol-emic homozygotes with ldl-c > 200 mg/dl and documented coronary artery disease.