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FDA Sets Review Period For Guidant Radiotherapy System

05/21/2007

Federal Register Notice: FDA has determined the regulatory review period for Guidant Corp.’s Galileo Intravascular Radiotherapy System is 1,523 days.for extending a patent which claims that medical device. The Galileo is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention for treating in-stent restenosis in native coronary arteries with discrete lesions < = 47 mm in a reference vessel diameter 2.4 mm to 3.7 mm. To view this notice, click here.

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