|
Device | THERAKOS UVAR XTS 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 | S079 |
Date Received | 03/13/2015 |
Decision Date | 04/16/2015 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE ON POST STERILIZATION AERATION CYCLE TIMES FOR THE THERAKOS CELLEX PHOTOPHERESIS SYSTEMS. |