Identity
- Trade Name
- Symmetry™ VNS Therapy Kit Model 98142 FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- VNS Therapy Kit FDA UDI
- Model / Reference
- 98142 FDA UDI
- Description
- VNS Therapy Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750511 FDA UDI
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- MUZ FDA UDI
- GMDN Term
- Vascular graft tunneller 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Length — 2 Millimeter FDA UDI
Category: Vascular graft tunnellerAntiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation systemVagus nerve electrical stimulation system lead
Symmetry™ VNS Therapy Kit Model 98142 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 lead.
- Paired VNS — Microtransponder · Class III
- Paired VNS — Microtransponder · Class III
- VNS Therapy® Model 302 Lead — LivaNova USA, Inc. · Class III
- VNS Therapy® Model 302 Lead — LivaNova USA, Inc. · Class III
- VNS Therapy® PerenniaDURA® Model 303 Lead — LivaNova USA, Inc. · Class III
Cleared under the same submission
P970003 also covers:
- NCP® Programming Wand Model 201 — 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.
- VNS Therapy® Programmer, Model 3000 v1.0 — LivaNova USA, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 6f9d3249-7917-4a03-9750-ecd9b7fbed06 37 fields · synced Jun 8, 2026
- EUDAMED 1 fields · synced May 22, 2026