Altius Direct Electrical Nerve Stimulation System
FDA premarket approval P230020/S002 · decided 2025-05-06
Approval details
- PMA number
- P230020
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Altius Direct Electrical Nerve Stimulation System
- Generic name
- stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
- Applicant
- Neuros Medical, Inc.
- Date received
- 2025-02-14
- Decision date
- 2025-05-06
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- SAZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for an Altius Implantable Pulse Generator (IPG) Accessory Kit that includes a spare sterile port plug and torque wrench.
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