|
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 | S090 |
Date Received | 05/22/2017 |
Decision Date | 07/21/2017 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for a design change to replace the 24 V power supply in the device. |