PMA P240036S004

Device: OmniaSecure™ MRI SureScan™ Lead Model 3930M
Applicant: Medtronic, Inc.
PMA number: P240036
Supplement: S004
Product code: NVY
Decision date: 2026-03-09
Classification: Cardiovascular
Generic name: Permanent defibrillator electrodes
Approval order statement: Approval for updated indications and labeling changes with Left Bundle Branch Area Pacing (LBBAP) application for the OmniaSecure™ MRI SureScan™ 3930M lead

Current openFDA PMA Record#

Device: OmniaSecure™ MRI SureScan™ Lead Model 3930M
Applicant: Medtronic, Inc.
PMA number: P240036
Supplement: S004
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2026-03-09
Decision code: APPR
Date received: 2025-12-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updated indications and labeling changes with Left Bundle Branch Area Pacing (LBBAP) application for the OmniaSecure™ MRI SureScan™ 3930M lead