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VNS Therapy®
EUDAMEDFDA UDIClass AIMDD (EU MDR)
Ref 103Model Model 103Ref 303-20Model Model 303-20Ref 304-30Model Model 304-30Ref 3000v1.6.2Model Model 3000v1.6.2Ref 3000v1.6.1Model Model 3000v1.6.1Ref 304-20Model Model 304-20
Identity
- Trade Name
- VNS Therapy® EUDAMEDVNS Therapy® PerenniaFLEX® Model 304 Lead FDA UDIVNS Therapy® Programmer, Model 3000 v1.6.2 FDA UDIVNS Therapy® Programmer, Model 3000 v1.6 FDA UDIVNS Therapy® PerenniaDURA® Model 303 Lead FDA UDIVNS Therapy® Demipulse® Model 103 Generator FDA UDI
- Generic Name
- Vagus nerve electrical stimulation system lead FDA UDIVagus nerve electrical stimulation system programmer FDA UDIAntiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
- Device Name
- VNS Therapy® Demipulse® Generator EUDAMEDVNS Therapy® PerenniaDURA® Lead EUDAMEDVNS Therapy® PerenniaFLEX® Lead EUDAMEDVNS Therapy® Programmer EUDAMEDImplantable Lead FDA UDIProgrammer FDA UDIImplantable Pulse Generator FDA UDI
- Model / Reference
- Model 103 EUDAMED103 EUDAMEDFDA UDI304-20 EUDAMEDFDA UDI304-30 EUDAMEDFDA UDI303-20 EUDAMEDFDA UDIModel 303-20 EUDAMEDModel 304-30 EUDAMEDModel 3000v1.6.2 EUDAMED3000v1.6.2 EUDAMEDModel 3000v1.6.1 EUDAMED3000v1.6.1 EUDAMEDModel 304-20 EUDAMED3000 FDA UDI
- Description
- Implantable Lead FDA UDIProgrammer FDA UDIImplantable Pulse Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750030 EUDAMEDFDA UDI05425025750139 EUDAMEDFDA UDI05425025750153 EUDAMEDFDA UDI05425025750535 EUDAMEDFDA UDI05425025750443 EUDAMEDFDA UDI05425025750115 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05425025750030 EUDAMEDB-05425025750115 EUDAMEDB-05425025750153 EUDAMEDB-05425025750535 EUDAMEDB-05425025750443 EUDAMEDB-05425025750139 EUDAMED
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- MUZ FDA UDILYJ FDA UDI
- EMDN Code
- J020301,J020399 EUDAMEDJ020302 VAGAL NEUROSTIMULATION LEADS EUDAMEDJ020701 NEUROSTIMULATORS PROGRAMMERS EUDAMED
- GMDN Term
- Vagus nerve electrical stimulation system lead FDA UDIVagus nerve electrical stimulation system programmer FDA UDIAntiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Special Device Type
- -1200 EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.0 Millimeter FDA UDIOuter Diameter — 3.0 Millimeter FDA UDI
VNS Therapy® by LivaNova USA, Inc. — Class AIMDD — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05425025750030 | Class AIMDD | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class AIMDD | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
- EUDAMED SRN
- US-MF-000038770
- Authorised Representative
- LivaNova Belgium NV BE-AR-000014035
Sources (12)
- EUDAMED 29ef0a95-a68f-4f5e-ad85-75deb085796d 61 fields · synced Jul 23, 2026
- FDA UDI 49bd6777-9579-4d84-8095-302e5f8c5d82 37 fields · synced May 29, 2026
- FDA UDI e4dcd7c0-4105-4678-a5bd-deb94437eee9 37 fields · synced May 30, 2026
- FDA UDI 8919d67f-a603-4a40-93aa-812b0ccc0d8c 36 fields · synced May 30, 2026
- FDA UDI dadb8367-fc61-4139-b068-82f168000081 36 fields · synced May 30, 2026
- FDA UDI 6a7451f5-b580-46b2-a683-0c155d26a706 37 fields · synced May 30, 2026
- FDA UDI 8b518f49-3bc5-46f0-893c-38695fc6cecb 36 fields · synced May 30, 2026
- EUDAMED d8848de9-3fe1-4446-960c-745c7d9fd9b2 61 fields · synced Jul 9, 2026
- EUDAMED 709d6b98-f028-4ec2-91e8-9ac9e09cd313 61 fields · synced Jul 18, 2026
- EUDAMED c1e6f9a1-f59e-4dff-bf3d-0f9317819ca8 61 fields · synced Jul 19, 2026
- EUDAMED 4b0c0d0b-772a-4004-b240-7f100567eba8 61 fields · synced Jul 21, 2026
- EUDAMED e105cf41-a777-494e-ac7d-efed0817e136 61 fields · synced Jul 23, 2026