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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOmniaSecure™ MRI SureScan™ Lead Model 3930M
Generic NamePermanent defibrillator electrodes
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP240036
Supplement NumberS004
Date Received12/09/2025
Decision Date03/09/2026
Product Code NVY 
Advisory Committee Cardiovascular
Clinical TrialsNCT04863664
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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
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