Identity
- Trade Name
- Altius IPG FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Model / Reference
- FG-601-000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810118490002 FDA UDI
- PMA Number
- P230020 FDA UDI
- FDA Product Code
- SAZ 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 Unsafe FDA UDI
Altius IPG by Neuros 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
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
- PNS Freedom-8A Permanent Neurostimulator Spare Kit Channel A — Curonix · Class II
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
- Vanta™ AdaptiveStim™ — MEDTRONIC, INC. · Class III
- Evoke® Closed-Loop Stimulator (CLS) — SALUDA MEDICAL PTY LIMITED · Class III
- Precision™ Montage™ MRI — Boston Scientific Neuromodulation · Class III
- Freedom System Accessory — Curonix · Class II
Cleared under the same submission
P230020 also covers:
- Altius Battery Charger — Neuros Medical, Inc.
- Altius Cuff Large — Neuros Medical, Inc.
- Altius Cuff Medium — Neuros Medical, Inc.
- Altius Cuff Small — Neuros Medical, Inc.
- Altius IPG Accessory Kit — Neuros Medical, Inc.
- Altius Patient Controller — Neuros Medical, Inc.
- Altius Programmer Wand — Neuros Medical, Inc.
- Altius Programming Application PC — Neuros 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
- Neuros Medical, Inc.
Sources (1)
- FDA UDI 40b73925-9978-44d9-99ce-093ff4850c6d 33 fields · synced May 30, 2026