|
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 | S044 |
Date Received | 06/14/2006 |
Decision Date | 07/14/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON EXTRACORPOREAL BLOOD VOLUME MANAGEMENT AND THE IMPORTANCE OF TESTING PATIENTS' HEMATOCRIT VALUES. |