FDA approves Biotronik's Eluna MRI-safe pacemaker

Biotronik says it won pre-market approval from the FDA for its Eluna MRI-safe pacemaker.

Biotronik said today that the FDA approved its ProMRI Eluna MRI-safe pacemaker, making it the only company with single- and dual-chamber MRI-safe pacemakers on the U.S. market.

Biotronik, Food & Drug Administration (FDA)

News Well, Cardiac Rhythm Management, Pre-Market Approval (PMA), Regulatory/Compliance

read more

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1LAeZuT