Identity
- Trade Name
- Infinity™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- Patient Manual and Magnet FDA UDI
- Model / Reference
- 6884 FDA UDI
- Description
- Patient Manual and Magnet FDA UDI
Identifiers
- Catalog Number
- 6884 FDA UDI
- Primary DI / UDI-DI
- 05415067023988 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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
Similar devices
Also classified as Deep brain electrical stimulation system.
- Percept™ PC BrainSense™ — MEDTRONIC, INC. · Class III
- Vercise™ — Boston Scientific Neuromodulation · Class III
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- Vercise™ Cartesia™ — Boston Scientific Neuromodulation · Class III
- MEDTRONIC® DBS™ — MEDTRONIC, INC. · Unclassified
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI c0f255b8-174e-4038-8e06-0bf8af5845ae 36 fields · synced May 30, 2026