|
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 | S022 |
Date Received | 10/17/2016 |
Decision Date | 11/15/2016 |
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 Substitution of the Transducer Protector present in the H.E.L.P lines with a new configuration. |