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Boston Scientific

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application supplement for NIR-On-Ranger coronary stent with Sox securement system is submitted to FDA July 28, the company says. The submission occurs nearly ten months after the firm voluntarily recalled the product on Oct. 5, 1998 due to higher than anticipated balloon failure rates (1"The Gray Sheet" Oct. 12, 1998, p. 28). Recall of the device commenced eight weeks after its launch
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