St. Jude's Microny SR+ 2425T
This article was originally published in The Gray Sheet
Executive Summary
U.S. launch of the single-chamber, rate-responsive pacemaker will await future enhancements to be cleared via PMA supplement, following approval of the current version Dec. 21. Delay in approving St. Jude Medical's 1997 PMA application stems from FDA concerns relating to the device's sensor function, and the existing version is essentially obsolete without the planned improvements, the firm says. The device has been available in Europe since 1995