|Trade Name||MYOPORE SUTURELESS MYOCARDIAL PACING LEAD|
|Classification Name||permanent pacemaker electrode|
|Docket Number|| 15M-1557|
|Notice Date|| 05/08/2015|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the myopore sutureless myocardial pacing lead. This device is indicated for when ventricular epicardial attachment is required, or when a transvenous lead cannot provide effective pacing. This type of lead is useful in situations where it is required that the potential for lead dislodgement be diminished or pacing and/or sensing will be established subsequent to open heart surgery.