|
Device | UVAR(R) XTS(TM) 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 | S039 |
Date Received | 03/05/2001 |
Decision Date | 05/22/2001 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE MODIFICATIONS RELATED TO THE ENUMERATION OF BUFFY COAT MODE CYCLES AND TO THE COLLECTION VOLUME OF BUFFY COAT PRIOR TO THE IRRADIATION PROCESS. |