|
Device | PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.) |
Generic Name | Lipoprotein, low density, removal |
Applicant | B. Braun Avitum AG SCHWARZENBERGER WEG 73-79 MELSUNGEN D-342-3421 |
PMA Number | P940016 |
Supplement Number | S011 |
Date Received | 02/19/2009 |
Decision Date | 04/20/2009 |
Product Code |
MMY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN EXTENSION OF SHELF-LIFE FROM 5 YEARS TO 6 YEARS FOR THE PRECIPITATE FILTER COMPONENT OF THE DEVICE. |