|
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 | S102 |
Date Received | 02/03/2020 |
Decision Date | 07/31/2020 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for software Version 5.4 and for hardware modifications to the CELLEX® Photopheresis System, including changes to the servo drive electrical isolation hardware and to the Ballast Monitor and Lamp Rear printed circuit board assemblies. |