|Trade Name||SIR-SPHERES MICROSPHERES|
|Classification Name||microspheres radionuclide|
|Applicant||SIRTEX MEDICAL LIMITED|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a new cleanroom with two new production hot cells and associated equipment to existing manufacturing space.