> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves MRI-friendly Labeling for Abbott ICD and Leads
- URL: https://www.fdaweb.com/fda-approves-mri-friendly-labeling-for-abbott-icd-and-leads/
- Published: 2017-09-22T12:00:00.000Z
- Updated: 2026-09-14T22:52:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139691

FDA has approved magnetic resonance (MR)-conditional labeling for Abbott’s Ellipse implantable cardioverter defibrillator and associated Tendril MRI pacing lead and Durata and Optisure high voltage leads. Ellipse labeling allows patients to undergo an MRI scan if needed, and patients previously implanted with an Ellipse device and Durata or Optisure leads can now undergo MRI scans, the company says. Earlier this year, Abbott’s Assurity MRI pacemaker gained MR-conditional labeling approvals in Europe.