|
Device | H.E.L.P. SYSTEM |
Generic Name | Lipoprotein, low density, removal |
Applicant | B. Braun Avitum AG SCHWARZENBERGER WEG 73-79 MELSUNGEN D-342-3421 |
PMA Number | P940016 |
Date Received | 06/01/1994 |
Decision Date | 09/19/1997 |
Product Code |
MMY |
Docket Number | 98M-0138 |
Notice Date | 04/16/1998 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
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. |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S004 S009 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 |