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2 个月内
BRIEF-Globus Medical says received letter from FDA regarding 510(K) submission for Excelsiusgps
2017年5月17日 / 晚上8点37分 / 2 个月内

BRIEF-Globus Medical says received letter from FDA regarding 510(K) submission for Excelsiusgps

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May 17 (Reuters) - Globus Medical Inc

* Globus Medical - received letter from FDA informing co had not sufficiently addressed questions regarding 510(K) submission for Excelsiusgps

* Globus Medical - co had not sufficiently addressed FDA's questions within FDA review period required for clearance under rules governing 510(K) process

* Globus Medical - company intends to file a revised 510(K) submission for Excelsiusgps in an expedited fashion

* Globus Medical - in light of FDA correspondence, co no longer anticipates obtaining FDA clearance for Excelsiusgps during second calendar quarter

* Globus Medical - company reaffirms guidance for full year 2017 sales of $625 million and non-GAAP fully diluted earnings per share of $1.27 Source text for Eikon: (bit.ly/2qxJPgb) Further company coverage:

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