Altius Patient Controller FG-604-000
Altius Patient Controller FG-604-000 is a Class III device made by Neuros Medical, Inc., approved under FDA PMA P230020 on 26 Aug 2024 and listed in FDA GUDID since 23 Dec 2024 (UDI-DI 00810118490026), active as of 22 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810118490026 | Date23 Dec 2024 | StatusListed |
| United States | FDA PMAAPPR | NumberP230020 | Date26 Aug 2024 | StatusActive |
Official records
- AccessGUDID record 00810118490026
- FDA PMA database P230020
Across registries
- FDA PMA P230020 decided 26 Aug 2024 Active
- FDA GUDID UDI-DI 00810118490026 listed 23 Dec 2024 Listed
Timeline
- Approved FDA PMA P230020
- Listed FDA GUDID 00810118490026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Altius Patient Controller
- Generic name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unit
- Model / reference
- FG-604-000
- Primary DI / UDI-DI
- 00810118490026
- PMA number
- FDA product code
- SAZ
- GMDN term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unit
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution