Altius Direct Electrical Nerve Stimulation System
FDA premarket approval P230020/S003 · decided 2025-06-25
Approval details
- PMA number
- P230020
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- 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
- 2025-04-01
- Decision date
- 2025-06-25
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- SAZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- approval for a second battery charge current option of 100 mA, in addition to the battery charge current of 50 mA previously approved under the original PMA P230020.
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