Identity
- Trade Name
- Proclaim™ FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Device Name
- Implantable Pulse Generator FDA UDI
- Model / Reference
- DRG FDA UDI
- Description
- Implantable Pulse Generator FDA UDI
Identifiers
- Catalog Number
- 3664 FDA UDI
- Primary DI / UDI-DI
- 05415067020215 FDA UDI
- PMA Number
- P150004 FDA UDI
- FDA Product Code
- PMP 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
Yes
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
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Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable.
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Cleared under the same submission
P150004 also covers:
- NeuroSphere™ — Advanced Neuromodulation Systems
- Proclaim™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, 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 9ecd9841-c6a8-416b-8166-eae8b243e55f 37 fields · synced May 30, 2026