VNS Therapy® PerenniaDURA® Model 303 Lead
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- VNS Therapy® EUDAMEDVNS Therapy® PerenniaDURA® Model 303 Lead FDA UDI
- Generic Name
- Vagus nerve electrical stimulation system lead FDA UDI
- Device Name
- VNS Therapy® PerenniaDURA® Lead EUDAMEDImplantable Lead FDA UDI
- Model / Reference
- 303-30 EUDAMEDFDA UDIModel 303-30 EUDAMED
- Description
- Implantable Lead FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425025750122 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05425025750122 EUDAMED
- PMA Number
- P970003 FDA UDI
- FDA Product Code
- MUZ FDA UDILYJ FDA UDI
- EMDN Code
- J020302 VAGAL NEUROSTIMULATION LEADS EUDAMED
- GMDN Term
- Vagus nerve electrical stimulation system lead FDA UDI
Classification
- Device Class
- Class AIMDD EUDAMEDClass III FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
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
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 3.0 Millimeter FDA UDI
Category: Vagus nerve electrical stimulation system lead
VNS Therapy® PerenniaDURA® Model 303 Lead 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
- Symmetry™ VNS Therapy Kit Model 98142 — 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® 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 acc92135-9333-467b-b4d2-493bf5b8a19f 37 fields · synced Oct 5, 2026
- EUDAMED 37b1b662-fe62-46e2-9380-5781ec198266 61 fields · synced Oct 5, 2026