Globus management says it intends to file a revised 510(k) submission for the system in "an expedited fashion." Management also stated it remains confident in its ability to adequately satisfy all the issues identified by the FDA. The FDA letter, according to the company's filing, stated the agency does not believe the company has "sufficiently addressed" the agency's questions regarding the robotic system "within the FDA review period." The company issued an SEC filing on regarding the FDA's notification letter dated two days earlier. that the agency is not granting 510(k) clearance for the company's ExcelsiusGPS robotic guidance and navigation system. The FDA has informed Globus Medical, Inc.
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