|
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 | S032 |
Date Received | 08/26/1998 |
Decision Date | 09/01/1998 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton. |