|
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 | S041 |
Date Received | 04/01/2002 |
Decision Date | 11/25/2002 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MACK MOLDING COMPANY, ARLINGTON, VERMONT. THE FACILITY WILL MANUFACTURE THE XTS INSTRUMENT AND XT20 LIGHT ASSEMBLY. |