Myopore Sutureless Myocardial Pacing Lead

FDA premarket approval P130012 · permanent pacemaker Electrode

PMA numberP130012

Approval

Applicant
Great Batch Medical
Received
May 13, 2013
Decision date
April 30, 2015 (APPR)
Supplements
13, latest April 19, 2024
Product code
DTB – Permanent Pacemaker Electrode

Official FDA PMA record

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.