One Boston Scientific warning letter down
This article was originally published in The Gray Sheet
Executive Summary
Guidant's December 2005 FDA warning letter blocking PMA approvals for certain cardiac rhythm management devices is lifted April 16 following resolution of quality system deficiencies at Boston Scientific's St. Paul, Minn. CRM facility, acquired from Guidant last year. With the regulatory restrictions removed, Boston Scientific gained five approvals for software upgrades and enhancements to CRM products on April 17. The same day, the firm also announced FDA approval of its Acuity steerable left ventricular lead, expected to launch in July for use with cardiac resynchronization devices. Boston Scientific plans to be ready for inspections related to its January 2006 corporate quality systems warning letter by June (1"The Gray Sheet" Feb. 5, 2007, p. 6)...
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