Identity
- Trade Name
- Axium™ FDA UDI
- Generic Name
- Implantable spinal cord electrical stimulation system programmer FDA UDI
- Device Name
- Patient Programmer Kit FDA UDI
- Model / Reference
- MN10600-02 FDA UDI
- Description
- Patient Programmer Kit FDA UDI
Identifiers
- Catalog Number
- MN10600-02 FDA UDI
- Primary DI / UDI-DI
- 05415067025586 FDA UDI
- PMA Number
- P150004 FDA UDI
- FDA Product Code
- PMP FDA UDI
- GMDN Term
- Implantable spinal cord electrical stimulation system programmer 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
No
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
MR Unsafe FDA UDI
Category: Implantable spinal cord electrical stimulation system programmer
Axium™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable spinal cord electrical stimulation system programmer.
- mySCS™ GO — Boston Scientific Neuromodulation · Class III
- Wearable Antenna Assembly/StimQ Wearable Antenna Gear — STIMWAVE TECHNOLOGIES INCORPORATED · Class II
- Senza® — Nevro Corporation · Class III
- Nevro® — Nevro Corporation · Class III
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Omnia — Nevro Corporation · Class III
- Evoke® Pocket Console (EPC) — SALUDA MEDICAL PTY LIMITED · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI b4463d64-db5c-4528-9c03-eb2a0b87f065 37 fields · synced Jun 1, 2026