> ## 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 First Leadless Pacemaker
- URL: https://www.fdaweb.com/fda-approves-first-leadless-pacemaker/
- Published: 2016-04-06T12:00:00.000Z
- Updated: 2026-09-14T20:53:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135302

> FDA has approved a Medtronic PMA for the Micra Transcatheter Pacing System, the first pacemaker that does not require wired leads to provide an electrical connection between the pulse-generating device and the heart. The self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart, an [FDA release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494417.htm?ref=fdaweb.com) says.  
>  
> “The leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions,” the agency says. “Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.”  
>  
> Approval was based on data from a clinical trial involving 719 patients implanted with the Micra device. The data showed that 98% patients in the trial had adequate heart pacing six months after the device was implanted. Complications occurred in fewer than 7% of participants in the clinical trials and included prolonged hospitalizations, blood clots in the legs and lungs, heart injury, device dislocation and heart attacks.