|
Device | Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System |
Generic Name | Lipoprotein, low density, removal |
Applicant | B. Braun Avitum AG SCHWARZENBERGER WEG 73-79 MELSUNGEN D-342-3421 |
PMA Number | P940016 |
Supplement Number | S023 |
Date Received | 06/08/2017 |
Decision Date | 07/06/2017 |
Product Code |
MMY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Qualification of an additional clean room area for the B. Braun Avitum Italy Plant for the manufacturing of the H.E.L.P Futura Set. |