Home » Medtronic Gains Expanded FDA Nod for Pacing Leads
Medtronic Gains Expanded FDA Nod for Pacing Leads
Devices Submissions and Approvals
The FDA granted expanded labeling for Medtronic’s SelectSecure magnetic resonance imaging SureScan model 3830 cardiac leads for pacing of the muscle fibers that conduct the electrical impulses that regulate heartbeat.
The bipolar, steroid-eluting leads attach to a single or dual chamber pacemaker and now have approval for sensing and pacing in the atrium or right ventricle.
The leads are also approved for sensing and pacing at the atrioventricular bundle as an alternative to right ventricle placing.