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Device | THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S083 |
Date Received | 01/12/2016 |
Decision Date | 04/08/2016 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a change in the color scheme of the anticoagulant line from green-striped to orange-striped, and in the color of the anticoagulant spike chamber from white to orange. |