|
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 | S020 |
Date Received | 11/02/2015 |
Decision Date | 03/17/2016 |
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 manufacturer for your sodium chloride and acetate buffer solution bags. |