Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Deep brain electrical stimulation system FDA UDI
- Device Name
- DBS External Pulse Generator, 16 Channel FDA UDI
- Model / Reference
- 6599 FDA UDI
- Description
- DBS External Pulse Generator, 16 Channel FDA UDI
Identifiers
- Catalog Number
- 6599 FDA UDI
- Primary DI / UDI-DI
- 05415067023667 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Deep brain electrical stimulation system
Sjm™ 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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- 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.
- Infinity™ — 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 dccee602-bb0a-437d-a1ec-1b6d4880272c 37 fields · synced May 30, 2026