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Devices & Diagnostics Letter
June 21, 2010 | Vol. 37 No. 25
FDA Acknowledges Corrections, Sends Optovue Warning Letter
Although Optovue is taking corrective action to bring a normative database used with its RTVue optical coherence tomography into compliance, it received a warning letter that notes the effectiveness of the corrections can’t be fully reviewed and evaluated because they are ongoing.
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