Identity
- Trade Name
- Proclaim™ FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- Plus 5 Implantable Pulse Generator FDA UDI
- Model / Reference
- 3670 FDA UDI
- Description
- Plus 5 Implantable Pulse Generator FDA UDI
Identifiers
- Catalog Number
- 3670 FDA UDI
- Primary DI / UDI-DI
- 05415067046383 FDA UDI
- PMA Number
- P010032 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Proclaim™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable.
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- PNS Freedom-8A Permanent Neurostimulator Spare Kit Channel A — Curonix · Class II
- Vanta™ AdaptiveStim™ — MEDTRONIC, INC. · Class III
- Evoke® Closed-Loop Stimulator (CLS) — SALUDA MEDICAL PTY LIMITED · Class III
- Altius IPG — Neuros Medical, Inc. · Class III
- Precision™ Montage™ MRI — Boston Scientific Neuromodulation · Class III
- Freedom System Accessory — Curonix · Class II
- Spectra WaveWriter™ — Boston Scientific Neuromodulation · Class III
Cleared under the same submission
P010032 also covers:
- Eon Mini™ — Advanced Neuromodulation Systems
- Lamitrode® — Advanced Neuromodulation Systems
- Lamitrode® — Advanced Neuromodulation Systems
- Lamitrode® — Advanced Neuromodulation Systems
- Quattrode® — Advanced Neuromodulation Systems
- Quattrode® — Advanced Neuromodulation Systems
- Eon C™ — ST. JUDE MEDICAL, INC.
- Eon Mini™ — ST. JUDE MEDICAL, INC.
- Eon Mini™ — ST. JUDE MEDICAL, INC.
- Eon™ — ST. JUDE MEDICAL, INC.
- Exclaim™ — ST. JUDE MEDICAL, INC.
- Exclaim™ — 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 742eb12e-884c-425d-af16-da8c726d4bdb 37 fields · synced Jun 6, 2026