Identity
- Trade Name
- Infinity™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- Implantable Pulse Generator FDA UDI
- Model / Reference
- 7 FDA UDI
- Description
- Implantable Pulse Generator FDA UDI
Identifiers
- Catalog Number
- 6662 FDA UDI
- Primary DI / UDI-DI
- 05415067030023 FDA UDI
- PMA Number
- P140009 FDA UDI
- FDA Product Code
- MHY FDA UDI
- GMDN Term
- Deep brain 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Deep brain electrical stimulation system
Infinity™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Deep brain electrical stimulation system.
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- Vercise™ — Boston Scientific Neuromodulation · Class III
Cleared under the same submission
P140009 also covers:
- Liberta RC™ — Advanced Neuromodulation Systems
- NeuroSphere™ — Advanced Neuromodulation Systems
- Infinity™ — ST. JUDE MEDICAL, INC.
- Infinity™ — ST. JUDE MEDICAL, INC.
- Infinity™ — ST. JUDE MEDICAL, INC.
- Infinity™ — ST. JUDE MEDICAL, INC.
- Infinity™ — ST. JUDE MEDICAL, INC.
- Infinity™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- SJM™ — ST. JUDE MEDICAL, INC.
- St. Jude Medical Infinity™ — ST. JUDE MEDICAL, INC.
- St. Jude Medical Infinity™ — ST. JUDE MEDICAL, 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
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI b9ed1815-9965-4a44-b9d1-7d2aa5fe015d 37 fields · synced Jun 8, 2026