|
Device | Therakos Cellex Photopheresis System |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S097 |
Date Received | 10/30/2017 |
Decision Date | 01/26/2018 |
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 design change to the air detector used in the CELLEX Photopheresis System. |