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People Briefs: Resignations At Cambridge Heart; Appointments At Sun Diagnostics, Cook Medical

This article was originally published in The Gray Sheet

Executive Summary

Cambridge Heart’s chairman and former CEO both resign. Sun Diagnostics names new CEO. Cook Medical promotes head of peripheral intervention division to executive VP.

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People Briefs: MDMA Board Adds; Appointments At Insulet, MedLumics, Cardiva, Cardica

Industry veteran Jim Mazzo joins Medical Device Manufacturers Association board, along with three others. Insulet, MedLumics, Cardiva and Cardica announce appointments. More people briefs.

Shutdown Realities At FDA: No New Submission Reviews, And More

New PMA and 510(k) submissions, and anything else tied to an FY 2014 user fee payment, are not being reviewed by FDA as of Oct. 1. The limited carryover-FY 2013 user fees FDA has are supporting ongoing reviews, while the registration and listing and export certification database entry systems are unavailable.

Cook Recalls Zilver Drug-Eluting Stent Due To Catheter Separation Issue

Cook Medical has stopped shipments and initiated a global recall of its Zilver PTX drug-eluting stent due to reports of the device’s delivery system separating at the tip of the inner catheter.

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