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Challenges With ICD Leads Are Under Control, St. Jude Tells Investors

This article was originally published in The Gray Sheet

Executive Summary

The company was prepared for FDA’s recent warning letter, executives said on an earnings call. But the scrutiny is not over, analysts suggest.

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Regulatory Roundup: St. Jude Resolves Warning Letter; Classifications; IMDRF

FDA formally closed out St. Jude Medical’s warning letter that had cited deficiencies at the firm’s California defibrillator lead facility. The agency finalizes two de novo classifications. The International Medical Device Regulators Forum is set to meet in Washington, D.C., in September.

St. Jude Warning Letter Updates: CRM Facility Reinspected; Neuro Plant Awaits FDA Visit

St. Jude updated the status of its efforts to resolve FDA warnings letters linked to its cardiac rhythm management and neuromodulation divisions during its first-quarter earnings call on April 16.

St. Jude Announces CRM Approvals, Progress With Warning Letter

FDA approval of several St. Jude Medical’s new cardiac rhythm management devices, including a new defibrillator lead, suggest the agency is largely satisfied with the company’s steps to resolve a January 2013 warning letter.

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