|
Device | UVAR XTS 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 | S051 |
Date Received | 12/18/2008 |
Decision Date | 01/16/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement TRANSFER OF THREE (3) UVAR XTS PHOTOPHERESIS PROCEDURAL KIT FINISHED PRODUCT QUALITY CONTROL TEST TO A CONTRACT TESTING LABORATORY. |