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Johnson & Johnson

This article was originally published in The Gray Sheet

Executive Summary

Firm's Cordis subsidiary currently has no plans to submit a PMA supplement for elective stenting with its Mini Crown coronary stent system, as was earlier being considered by the company ("The Gray Sheet" April 26, p. 7). The device, available in diameters of 2.25-3.25 mm, is approved for treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary lesions. Approval of 2.5 mm versions of competing stents from Guidant (Duet) and Boston Scientific (Nir) also is limited to abrupt or threatened closure, although 3.0 mm and larger versions of those devices are approved for broader indications for first-line therapy
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