H.E.L.P. System

FDA premarket approval P940016 · Lipoprotein, low density, removal

PMA numberP940016

Approval

Applicant
B. Braun Avitum AG
Received
June 1, 1994
Decision date
September 19, 1997 (APPR)
Supplements
20, latest June 7, 2019
Product code
MMY – Lipoprotein, Low Density, Removal

Official FDA PMA record

Approval order statement

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.