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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namepermanent pacemaker electrode
Regulation Number870.3680
PMA NumberP130012
Date Received05/15/2013
Decision Date04/30/2015
Product Code
DTB[ Registered Establishments with DTB ]
Docket Number 15M-1557
Notice Date 05/08/2015
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: 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.
Approval Order Approval Order