With ICD Leads Under Scrutiny, FDA Expects To Update Guidance In 2008
This article was originally published in The Gray Sheet
Executive Summary
FDA plans to release new PMA guidelines for pacemaker and implantable defibrillator leads in 2008 to give manufacturers more guidance on bench testing
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Remote Monitoring Databases Should Also Track Pacing Leads, Experts Say
Cardiac rhythm management device manufacturers say they will register cardiac leads separately in ICD and pacemaker remote monitoring databases to better track post-market lead performance