OmniaSecure™ MRI SureScan™ Lead Model 3930M

FDA premarket approval P240036 · Permanent defibrillator electrodes

PMA numberP240036

Approval

Applicant
Medtronic, Inc.
Received
October 18, 2024
Decision date
April 22, 2025 (APPR)
Supplements
6, latest April 24, 2026
Product code
NVY – Permanent Defibrillator Electrodes

Official FDA PMA record

Approval order statement

The Model 3930M lead is intended for single use in the right ventricle for pacing, sensing, cardioversion, and defibrillation when a cardiac implantable electronic device is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias.This includes adolescent pediatric patients who are at least 30 kg and are also at least 12 years of age, and whose cardiac anatomy is conducive to RV coil placement.