NVY · Permanent Defibrillator Electrodes
· Class 3
Overview
| Product Code | NVY |
|---|---|
| Device Name | Permanent Defibrillator Electrodes |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240036 | OmniaSecure MRI SureScan Lead Model 3930M | Medtronic, Inc. | Apr 22, 2025 | APPR |
| P920015 | MEDTRONIC(R) TRANSVENE LEAD SYSTEM | Medtronic, Inc. | Dec 9, 1993 | APPR |
Top Applicants
- Medtronic, Inc. — 2 clearances
