|
Device | THERAKOS CELLEX PHOTOPHERESIS SYSTEMS |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S062 |
Date Received | 09/29/2011 |
Decision Date | 10/28/2011 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A TECHNICAL BULLETIN THAT WILL BE SENT OUT TO USERS OF THE CELLEX¿ SYSTEM. |