Identity
- Trade Name
- Altius Programming Application PC FDA UDI
- Generic Name
- Implantable electrical stimulation device management software FDA UDI
- Model / Reference
- FG-608-000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810118490064 FDA UDI
- PMA Number
- P230020 FDA UDI
- FDA Product Code
- SAZ FDA UDI
- GMDN Term
- Implantable electrical stimulation device management software FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Implantable electrical stimulation device management software
Altius Programming Application PC by Neuros Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable electrical stimulation device management software.
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation · Class III
- ReActiv8 Programmer — MAINSTAY MEDICAL LIMITED · Class III
- SureTune™ 4 — MEDTRONIC, INC. · Class II
- Bionic Navigator™ — Boston Scientific Neuromodulation · Class III
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation · Class III
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- SureTune™ 4 — MEDTRONIC, INC. · 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 — Neuros Medical, Inc.
- Altius IPG Accessory Kit — Neuros Medical, Inc.
- Altius Patient Controller — Neuros Medical, Inc.
- Altius Programmer Wand — 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 3490a06f-b56c-439e-b919-6eeb527ba4e6 33 fields · synced May 31, 2026