Model 5071 Lead

FDA premarket approval P120017 · permanent pacemaker Electrode

PMA numberP120017

Approval

Applicant
Medtronic, Inc.
Received
October 4, 2012
Decision date
April 27, 2015 (APPR)
Supplements
40, latest April 15, 2026
Product code
DTB – Permanent Pacemaker Electrode

Official FDA PMA record

Approval order statement

APPROVAL FOR UNIPOLAR VENTRICULAR PACING AND SENSING. THE LEAD HASAPPLICATION WHERE PERMANENT VENTRICULAR OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. TWO LEADS MAY BE USED FOR BIPOLAR PACING.