DevicePMAs@therightstef:P000052_S004 JSONTXT 11 Projects

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."