|Trade Name||GALILEO (TM) III INTRAVASCULAR RADIOTHERAPY SYSTEM|
|Classification Name||intravascular radiation delivery system|
|Generic Name||intravascular radiation delivery system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the galileo iii intravascular radiotherapy system. The device, as modified, will be marketed under the trade name galileo iii intravascular radiotherapy system and is indicated as follows: "the galileo iii intravascular radiotherapy system is intended to deliver beta radiation to the site of successful percutaneous coronary intervention (pci) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions <= 47 mm in a reference vessel diameter 2. 4 mm to 3. 7 mm. ".