|
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 | S070 |
Date Received | 01/24/2013 |
Decision Date | 02/19/2013 |
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 MANUFACTURING PROCESS CHANGE TO APPLY A CURRENTLY USED UV CURABLE ADHESIVE IN AN ADDITIONAL LOCATION WITHIN THE CELLEX PHOTOPHERESIS PROCEDURAL KIT. |