Device Dossier

Eledyn EB 10 - Catheter, cardiac, balloon, pacing electrode

Device Dossier for Eledyn EB 10 - Catheter, cardiac, balloon, pacing electrode (Catheter, cardiac, balloon, pacing electrode, Class III, sponsor B…

Intended purpose

Eledyn EB 10 is a bipolar balloon pacing catheter intended for temporary transvenous pacing or electrophysiological monitoring for patients with impaired impulse formation or conduction.

Functional description

The catheter transmits a pacing electrical stimulus from a pulse generator to the heart and/or an electrical signal of the heart to a recording device.

TGA Public Summary