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BRIEF-Isoray receives FDA response to application for Gammatile
2017年7月6日 / 中午12点28分 / 4 个月前

BRIEF-Isoray receives FDA response to application for Gammatile

July 6 (Reuters) - Isoray Inc

* Isoray receives FDA response to 510(k) application for Gammatile

* Has received a response from FDA regarding company’s pending application for Gammatile radiation therapy system

* FDA indicated need for co, co-applicant, to submit additional data within next 180 days as condition of securing clearance for novel Gammatile device

* As a result of FDA’s response, pending ntap application, which requires an FDA cleared product, will be resubmitted in fall of 2017

* Completion of additional testing anticipated by end of 2017, project potential 510(k) clearance of Gammatil product in first half of 2018 Source text for Eikon: Further company coverage:

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