|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||microspheres radionuclide|
|Applicant||SIRTEX MEDICAL LIMITED|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for additional warning on the label.