St. Jude's Integrity Micro DR
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement approval is received for a revised version of the firm's 3500/3510 programmer software to activate the dynamic atrial overdrive feature in its Integrity Micro DR Model 5336 pacemaker, intended to reduce incidence of atrial fibrillation in patients paced to treat bradycardia. The feature can now be activated in new Integrity Micro DRs or previously implanted devices. The new software can also be used to activate DAO in the Integrity AFx DR Model 5342. On July 12, the company began shipping Integrity AFx DR devices with the DAO already activated, following premarket approval of the algorithm's inclusion in new pacers, announced July 11. The Integrity Micro DR was approved in December 2000 but required the PMA supplement to activate the DAO feature (1"The Gray Sheet" July 16, 2001, p. 12)