Identity
- Trade Name
- VNS Therapy® Programmer, Model 3000 v1.0.2 FDA UDI
- Generic Name
- Vagus nerve electrical stimulation system programmer FDA UDI
- Device Name
- Programmer FDA UDI
- Model / Reference
- 3000 FDA UDI
- Description
- Programmer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750481 FDA UDI
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- LYJ FDA UDIMUZ FDA UDI
- GMDN Term
- Vagus nerve electrical stimulation system programmer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Vagus nerve electrical stimulation system programmer
VNS Therapy® Programmer, Model 3000 v1.0.2 by LivaNova USA, Inc. — Class III — FDA UDI — listed in FDA GUDID — 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® Model 250 v11.0 Programming Software — LivaNova USA, Inc. · Class III
- VNS Therapy® Programmer, Model 3000 v1.0 — 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 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.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI 10faca55-28fa-448e-aa2b-d48e8c3799be 36 fields · synced Jun 8, 2026