DevicePMAs@therightstef:P940016_S000 11 Projects
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Approval for the H. E. L. P. System. The device is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in perofrming LDL-C apheresis to acutely remove LDL-C from the plasma of high risk patient populations for whom diet has been ineffective or not tolerated.
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