VNS Therapy® Model 250 v11.0 Programming Software
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- VNS Therapy® EUDAMEDVNS Therapy® Model 250 v11.0 Programming Software FDA UDI
- Generic Name
- Vagus nerve electrical stimulation system programmer FDA UDI
- Device Name
- VNS Therapy® Software EUDAMEDProgramming Software FDA UDI
- Model / Reference
- Model 250v11.0 EUDAMED250v11.0 EUDAMED250 v11.0 FDA UDI
- Description
- Programming Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750375 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05425025750375 EUDAMED
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- LYJ FDA UDIMUZ FDA UDI
- EMDN Code
- J020701 NEUROSTIMULATORS PROGRAMMERS EUDAMED
- GMDN Term
- Vagus nerve electrical stimulation system programmer 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
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Vagus nerve electrical stimulation system programmer
VNS Therapy® Model 250 v11.0 Programming Software by LivaNova USA, Inc. — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vagus nerve electrical stimulation system programmer.
- Vivistim — Microtransponder · Class III
- Paired VNS — Microtransponder · Class III
- VNS Therapy® Programmer, Model 3000 v1.5 — LivaNova USA, Inc. · Class III
- NCP® Programming Wand Model 201 — LivaNova USA, Inc. · Class III
- VNS Therapy® Model 250 v10.0 Programming Software — LivaNova USA, Inc. · Class III
- VNS Therapy® Model 250 v8.1 Programming Software (X50) — LivaNova USA, Inc. · Class III
- VNS Therapy® Programmer, Model 3000 v1.0 — LivaNova USA, Inc. · Class III
- VNS Therapy™ Programmer, Model 3100 v1.1.0 — LivaNova USA, Inc. · Class III
Cleared under the same submission
P970003 also covers:
- NCP® Programming Wand Model 201 — LivaNova USA, Inc.
- Symmetry™ VNS Therapy Kit Model 98142 — LivaNova USA, Inc.
- VNS Therapy® Model 250 v10.0 Programming Software — LivaNova USA, Inc.
- VNS Therapy® Model 250 v10.0 Programming Software — LivaNova USA, Inc.
- VNS Therapy® Model 250 v11.0 Programming Software — LivaNova USA, Inc.
- VNS Therapy® Model 250 v8.1 Programming Software (X5) — LivaNova USA, Inc.
- VNS Therapy® Model 250 v8.1 Programming Software (X50) — LivaNova USA, Inc.
- VNS Therapy® Model 302 Lead — LivaNova USA, Inc.
- VNS Therapy® Model 302 Lead — LivaNova USA, Inc.
- VNS Therapy® Model 502 Accessory Pack — LivaNova USA, Inc.
- VNS Therapy® PerenniaDURA® Model 303 Lead — LivaNova USA, Inc.
- VNS Therapy® Programmer, Model 3000 v1.0 — LivaNova USA, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (2)
- FDA UDI 5340ec37-6763-4989-889a-96f4775ed02a 36 fields · synced Jul 10, 2026
- EUDAMED 09019b51-f601-4442-af3d-07b5fe32eca7 61 fields · synced Jul 10, 2026