|
Device | 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 | S027 |
Date Received | 09/28/2018 |
Decision Date | 06/07/2019 |
Product Code |
MMY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the cutting process in the manufacturing of the H.E.L.P. Ultrafilter HI PS 20 included in the H.E.L.P. Futura Set. |