| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
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| Generic Name | Permanent defibrillator electrodes |
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| Applicant | Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112 |
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| PMA Number | P240036 |
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| Date Received | 10/18/2024 |
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| Decision Date | 04/22/2025 |
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| Product Code |
NVY |
| Docket Number | 25M-1116 |
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| Notice Date | 04/30/2025 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT04863664
|
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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| Predetermined Change Control Plan Authorized | No |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 |
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