|
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 | S054 |
Date Received | 06/17/2009 |
Decision Date | 09/15/2009 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TRANSFER OF FINISHED PRODUCT TESTING TO STERIPRO LABS FROM THERAKOS, INC. |