Identity
- Trade Name
- Vivistim FDA UDI
- Generic Name
- Vagus nerve electrical stimulation system programmer FDA UDI
- Device Name
- Stroke Application and Programming Software FDA UDI
- Model / Reference
- 4001 FDA UDI
- Description
- Stroke Application and Programming Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810041430004 FDA UDI
- PMA Number
- P210007 FDA UDI
- FDA Product Code
- QPY 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vagus nerve electrical stimulation system programmer
Vivistim by Microtransponder — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vagus nerve electrical stimulation system programmer.
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- 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
- VNS Therapy™ Programmer, Model 3100 v1.1.0 — LivaNova USA, Inc. · Class III
- VNS Therapy® Model 250 v11.0 Programming Software — LivaNova USA, Inc. · Class III
Cleared under the same submission
P210007 also covers:
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
- Microtransponder
Sources (1)
- FDA UDI 6995be8a-22cc-452a-a3df-2733a82e5ce6 34 fields · synced May 30, 2026