Product code NVY ยท Class 3
Permanent Defibrillator Electrodes
0510(k)s in 12 months (0 all time)
1recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NVY
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 4 |
| Medtronic, Inc. | 0 | 1 |
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2026 | Medtronic, Inc. OmniaSecure Model 3930M,
LEAD 3930M74 74 CM DF4 MR
3930M74
LEAD 3930M79 79 CM DF4 MR
3930M79
The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting,
integrated bipolar, nonretractable scr Open, Classified |
NVY | None listed |
| Aug 20, 2025 | Boston Scientific Corporation RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696 Open, Classified |
NVY | None listed |
| Aug 20, 2025 | Boston Scientific Corporation ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296 Open, Classified |
NVY | None listed |
| Oct 31, 2022 | Boston Scientific Corporation EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. Open, Classified |
NVY | None listed |
| Oct 31, 2022 | Boston Scientific Corporation EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. Open, Classified |
NVY | None listed |
| Nov 8, 2021 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72 Terminated |
NVY | None listed |
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