|
Device | 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 | S095 |
Date Received | 08/16/2017 |
Decision Date | 09/14/2017 |
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 | Yes |
Approval Order Statement Manufacturing site change for the pressure dome assembly component of the Therakos CELLEX Photopheresis Procedural Kit used in the Therakos CELLEX Photopheresis System. |