Identity
- Trade Name
- VNS Therapy® Symmetry™ Model 8103 Generator FDA UDI
- Generic Name
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
- Device Name
- Implantable Pulse Generator FDA UDI
- Model / Reference
- 8103 FDA UDI
- Description
- Implantable Pulse Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750504 FDA UDI
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- MUZ FDA UDI
- GMDN Term
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
VNS Therapy® Symmetry™ Model 8103 Generator by LivaNova USA, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA UDI cf57a63a-27f0-499d-bdbf-32a333897972 36 fields · synced Jun 8, 2026