|
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 | S058 |
Date Received | 03/08/2011 |
Decision Date | 04/21/2011 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL STERILIZATION SITE LOCATED AT STERIGENICS US LLC IN CHARLOTTE, NORTH CAROLINA. |