|
Device | H.E.L.P. PLASMAT FUTURA 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 | S016 |
Date Received | 09/13/2013 |
Decision Date | 08/11/2015 |
Product Code |
MMY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE H.E.L.P. OPTIMIZED THERAPY (HOT) CONFIGURATION |