|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.|
|Trade Name||GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS|
|Classification Name||intravascular radiation delivery system|
|Generic Name||percutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process for guidant's p-32 source wire by using an alternate needle coating process and material.